ModifiedUnitedHealthcarePolicy CS050KY.09

Glaucoma Surgical Treatments (for Kentucky Only)

Medical policy governing coverage and medical necessity of glaucoma surgical treatments for members in Kentucky, including MIGS, canaloplasty, goniotomy/trabeculotomy, glaucoma drainage devices, and laser procedures.

Policy Summary

PayerUnitedHealthcare

PolicyGlaucoma Surgical Treatments (for Kentucky Only)

Policy CodePolicy CS050KY.09

Change TypeUpdated applicable CPT codespolicy history entry 03/01/2026

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionWhen submitting claims or prior authorization requests, use the updated applicable code list (including 1012T) and document baseline IOP and prior therapy.

SourceLink

POLICY UPDATE CHANGES

Updated list of applicable CPT codes to reflect annual edits; added 1012T.

Archived previous policy version CS050KY.08.

Updated list of applicable CPT codes to reflect annual edits; added 1012T.

Archived previous policy version CS050KY.08.

Kentucky onlyJurisdiction

≥20% IOP ↓MIGS performance expectation

137 patientsOMNI case series

78%OMNI med‑free at 6 mo

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1Policy history entries

Coverage Criteria for Glaucoma Surgical Treatments

MIGS and canaloplasty with cataract

Covered when ALL of the following are met

Adults combined with cataract: Goniotomy, trabeculotomy, canaloplasty (ab interno), or combined ab‑interno canaloplasty and trabeculotomy (e.g., OMNI, Streamline) are covered and medically necessary when performed in adults (age 19 years or older) in combination with cataract surgery to treat mild to moderate open‑angle glaucoma in patients currently being treated with ocular hypotensive medication.age >= 19; diagnosis: mild-to-moderate OAG; concomitant cataract surgery; on ocular hypotensive medication

Policy lists these procedures as proven and medically necessary when combined with phacoemulsification; case series (OMNI) demonstrate meaningful IOP and medication reductions through 6–12 months but were often single‑arm.

Trabecular microstents with cataract

Covered when ALL of the following are met

Stent with cataract: Trabecular microstent systems (iStent, iStent inject, Hydrus Microstent) are covered and medically necessary only when implanted in conjunction with cataract surgery to treat mild to moderate open‑angle glaucoma in adults currently treated with ocular hypotensive medication.concomitant cataract surgery; mild-to-moderate OAG; on ocular hypotensive medication; adult patients

Coverage aligns with FDA approvals specifying use only in combination with cataract surgery.

Glaucoma drainage devices (refractory)

Covered when ALL of the following are met

GDD for refractory glaucoma: Glaucoma drainage devices with extraocular reservoir or other indicated shunts (examples include XEN System, EX‑PRESS, Molteno implant, Baerveldt tube shunt, Ahmed valve, Krupin‑Denver valve) are covered and medically necessary for treatment of refractory glaucoma when medical and/or prior surgical treatments have failed or are inappropriate.refractory glaucoma after failed or inappropriate medical/surgical treatments

Descriptions of device types and meta‑analysis data support use in refractory cases and note variable comparative outcomes versus trabeculectomy.

Laser procedures

Covered procedures

Listed laser procedures: Laser iridotomy/iridectomy (e.g., Nd:YAG), laser iridoplasty, and laser ciliary body destruction (cyclophotocoagulation) are covered and medically necessary when performed for appropriate clinical indications (for example, LPI for pupillary block or prophylaxis in PACS as supported by RCT data).appropriate clinical indication (e.g., pupillary block, PACS prophylaxis, refractory glaucoma for cyclodestructive procedures)

Policy explicitly lists these laser procedures as proven and medically necessary; CPT/HCPCS codes provided for reference.

Pediatric goniotomy/trabeculotomy

Covered when ALL of the following are met

Pediatric indication: Goniotomy or trabeculotomy are covered and medically necessary for pediatric glaucoma in patients aged 18 years or less.age <= 18; diagnosis: pediatric glaucoma (e.g., primary congenital glaucoma)

Systematic reviews and RCT evidence support these procedures for pediatric glaucoma, with some techniques (e.g., microcatheter‑assisted trabeculotomy) showing superior short‑term outcomes.

Evidence summaries (no explicit coverage criteria)

Evidence summaries and comparative findings from trials and reviews (no explicit coverage decision language present in these excerpts).

Hydrus evidence: A multi‑site retrospective case series (92 eyes) of Hydrus combined with phacoemulsification demonstrated IOP and medication reductions at 24 months but lacked a randomized comparison group.

Fea et al. 2017b; limited by lack of control

EX‑PRESS evidence: Pooled RCT data and a 5‑year extension show EX‑PRESS implantation had higher complete success and fewer early complications compared with trabeculectomy through 1–3 years, with similar qualified success and medication reduction.

Sun et al. 2019 meta‑analysis; de Jong 2011 extension

Tube shunts vs trabeculectomy: Meta‑analyses report Ahmed and EX‑PRESS outcomes comparable to trabeculectomy for IOP with fewer adverse events; Baerveldt and XEN often achieve less IOP reduction than trabeculectomy but differ in complication profiles.

Luo 2023; Tseng 2017; Budenz 2011

Evidence summaries and implied coverage logic

Summarized clinical findings and implied coverage considerations from the evidence:

Laser peripheral iridotomy (LPI): Prophylactic LPI in eyes with PACS reduced development of PAC/PACG endpoints over 5 years (RCT evidence) and increases angle width with a favorable safety profile; many PACS eyes do not require further intervention whereas PAC/PACG eyes often do.

Baskaran et al. RCT and AAO assessment

Laser peripheral iridoplasty (LPIp): Evidence is inconsistent: small trials do not reliably show additional IOP lowering versus LPI alone; LPIp may be used as a second‑line option when appositional angle closure persists after LPI, but evidence quality is limited.

Cochrane review and small RCTs

Cyclodestructive procedures: Cochrane review evidence is inconclusive comparing cyclodestructive procedures with other treatments; adverse events reported include hypotony and phthisis bulbi, and these procedures are traditionally reserved for refractory glaucoma.

Chen et al. 2019; AAO guidance

Device-specific indication alignment

Coverage should align with device FDA-labeled indications and the strength of evidence; when procedures are FDA-approved only with cataract surgery, coverage is limited to that context unless strong evidence supports standalone use.

FDA-indicated combined cataract/MIGS: Devices that have FDA approval only for use in combination with cataract surgery (for example, iStent, iStent inject, Hydrus) should be covered only when the device is used in the approved combined‑procedure context (patient has visually significant cataract and mild‑to‑moderate OAG).concomitant cataract surgery per FDA indication; mild-to-moderate OAG

FDA approvals and AAO guidance indicate these devices are indicated for use with phacoemulsification.

Evidence threshold for standalone or investigational procedures

When considering coverage for standalone or newer MIGS (e.g., KDB standalone, ELT, FLIGHT, OCT-guided), criteria should require higher-quality evidence due to heterogeneity and limitations in current studies.

Evidence requirements for standalone/newer MIGS: Coverage for standalone or investigational MIGS procedures should be contingent on sufficient prospective, comparative, and longer‑term evidence demonstrating safety and durable IOP and medication reduction versus standard of care, with low risk of bias and adequate sample size and follow‑up.high-quality prospective comparative evidence with adequate follow-up

Document notes lack of randomized trials, short follow-up, small samples, and potential manufacturer conflicts for many standalone/newer MIGS studies.

The policy states that all other types of laser procedures not specifically listed as proven are considered unproven and not medically necessary for treating any type of glaucoma due to insufficient evidence of efficacy and/or safety. This general exclusion applies to laser approaches beyond the named, evidence‑supported procedures (for example, SLT/argon trabeculoplasty, LPI, LPIp, and cyclophotocoagulation are listed as proven when appropriate; other unlisted lasers lack adequate evidence).

Some clinical trials have entry criteria that limit applicability of their results. For example, the HORIZON/Hydrus trials excluded patients with secondary open‑angle glaucoma (SOAG) and limited comorbidity inclusion, which reduces generalizability of the findings to SOAG populations. Reviewers should therefore consider trial eligibility when applying outcomes to individual members or different glaucoma subtypes.

Within the reviewed evidence there are no procedural exclusions explicitly listed in these excerpts; however, multiple systematic reviews and comparative studies note gaps in high‑quality randomized controlled trial data for several devices and approaches. These evidence limitations are highlighted for implants such as XEN and for newer ab‑interno canaloplasty/trabeculotomy systems, and may inform payers to restrict coverage or require additional documentation pending stronger comparative data.

The evidence base for laser peripheral iridoplasty (LPIp) and for various cyclodestructive procedures (cyclophotocoagulation variants) is limited. A Cochrane review found that LPIp did not demonstrate consistent additional IOP reduction over LPI and was supported by small trials with high risk of bias. Similarly, a Cochrane review of cyclodestructive procedures concluded the available randomized trials were inconclusive, with limited outcome data and notable adverse events (e.g., hypotony, phthisis bulbi). These gaps indicate insufficient high‑quality evidence to broaden routine use beyond specific, refractory indications.

In the provided document excerpt there are no additional explicit procedural exclusions beyond the general statements that unlisted laser procedures are unproven. The policy does enumerate specific proven procedures (e.g., LPI, LPIp, cyclophotocoagulation) and notes other devices/procedures in evidence summaries, but it does not list further named exclusions in the cited segments.

Laser trabeculotomy approaches that are not FDA‑approved for glaucoma in the U.S. — including excimer laser trabeculostomy (ELT), femtosecond laser trabeculotomy (FLT/FLIGHT), and OCT‑guided laser trabeculotomy — are described in the document as having insufficient quality evidence and are considered investigational pending adequate safety and effectiveness data. Additionally, FDA labeling for some microstents (e.g., iStent inject, Hydrus) specifies use only in combination with cataract surgery (see device‑label guidance).

The document notes that use of the iStent inject in a standalone procedure would be considered off‑label, because the FDA approvals for iStent and iStent inject are limited to use in conjunction with cataract surgery. Coverage decisions should align with device‑specific labeled indications unless strong evidence supports standalone use.

Providers must follow applicable federal, state, and contractual benefit plan requirements when seeking coverage. The policy explicitly directs users to reference governing federal/state/contractual terms because those requirements may differ from the standard policy language and, in the event of conflict, the federal/state/contractual requirements govern. Prior authorization and payment are determined in the context of these applicable rules.

Consistent with the policy text, other or unlisted laser procedures for glaucoma are regarded as unproven and not medically necessary due to insufficient evidence of efficacy and/or safety. This statement is presented as a general NMN conclusion for lasers not otherwise enumerated as proven in the policy.

Systematic reviews and cohort series report that the XEN Gel Stent can reduce IOP and medication use but the evidence is largely nonrandomized with variable follow‑up and a high risk of bias. Reviews characterize XEN as having a potential but unproven benefit relative to trabeculectomy, with higher rates of postoperative interventions and inconsistent long‑term comparative data. These limitations are emphasized in the evidence summaries.

Pooled and systematic reviews do not show strong evidence that adding laser peripheral iridoplasty (LPIp) provides additional IOP lowering beyond LPI, and the Cochrane review of cyclodestructive procedures found inconclusive comparative results across small trials. Reported adverse events for cyclodestruction include hypotony and phthisis bulbi. Overall, the cited reviews conclude no consistent additional benefit of LPIp over LPI and insufficient evidence to clearly define the role of cyclodestructive procedures outside refractory settings.

Although the excerpts summarize evidence limitations and identify procedures with weak or insufficient data, they do not uniformly use explicit 'not medically necessary' labels for individual procedures within those evidence summaries. The document instead relies on broader exclusion language for unlisted laser procedures and highlights evidence gaps that may support NMN or investigational determinations in the absence of robust comparative data.

Standalone Kahook Dual Blade (KDB) goniotomy and other investigational laser trabeculotomy approaches lack robust prospective comparative long‑term evidence. ECRI and other assessments identified high risk of bias, small nonrandomized studies, and limited follow‑up for standalone KDB and newer laser trabeculotomy technologies (e.g., ELT, FLIGHT, OCT‑guided), indicating these approaches remain investigational without stronger evidence demonstrating safety and durable IOP/medication reduction versus established alternatives.

Within the cited document segments there are no explicit single‑sentence statements designating particular named procedures as 'not medically necessary' beyond the general policy assertion that unlisted laser procedures are unproven and not medically necessary. The policy instead uses broader exclusion language and evidence summaries to inform NMN or investigational conclusions.

Procedure, Device and CPT Coding

Applicable procedure codes (reference)mixed

0253T	Insertion of anterior segment aqueous drainage device, without extraocular reservoir, internal approach, into the suprachoroidal space.
0449T	Insertion of aqueous drainage device, without extraocular reservoir, internal approach, into the subconjunctival space; initial device.
0450T	Insertion of aqueous drainage device, without extraocular reservoir, internal approach, into the subconjunctival space; each additional device (List separately in addition to code for primary procedure).
0474T	Insertion of anterior segment aqueous drainage device, with creation of intraocular reservoir, internal approach, into the supraciliary space.
0621T	Trabeculostomy ab interno by laser.
0622T	Trabeculostomy ab interno by laser; with use of ophthalmic endoscope.
0671T	Insertion of anterior segment aqueous drainage device into the trabecular meshwork, without external reservoir, and without concomitant cataract removal, one or more.
0730T	Trabeculotomy by laser, including optical coherence tomography (OCT) guidance.
1012T	Motorized ab interno trephination of sclera (sclerostomy), or trabecular meshwork (trabeculostomy), 1 or more, including injection of antifibrotic agents, when performed.
65820	Goniotomy.

1–10 of 23

1/3

FDA device identifiers and predicate numbers referencedmixed

K062259	iTRACK Canaloplasty Ophthalmic Microcannula (Canaloplasty Ophthalmic Microcannula) - FDA PMN identifier.
K211680	Streamline Surgical System (Streamline Viscoelastic Injector) - FDA PMN identifier.
K030350	ExPRESS Mini Glaucoma Shunt - 501(k) approval identifier.
K161457	XEN Glaucoma Treatment System - FDA PMN identifier.
P170043	iStent inject - PMA identifier.
P170034	Hydrus Microstent - PMA identifier.

Applicable CPT Codes (updated)CPT

1012T

Newly added CPT code referenced in policy history (exact descriptor included in applicable codes list).

Applicable CPT Codes (partial—updated)CPT

1012T

Added CPT code per policy revision.

MIGS performance expectation — key metric (inv-28)

MIGS performance expectationProcedures should achieve at least a 20% reduction in intraocular pressure (IOP) or a reduction of at least one IOP‑lowering medication.

Typical approachPerformed via ab interno approach and commonly combined with phacoemulsification for mild‑to‑moderate glaucoma patients.

Target populationCandidates are usually those with mild to moderate open‑angle glaucoma not requiring very low target IOPs.

Authorization, Documentation and Operational Guidance

Billing Rule

Prior authorization: codes listed for reference

Applicable procedure and diagnosis codes are listed for reference only. Inclusion of a code in this policy does not guarantee coverage, reimbursement, or payment; benefits are determined by applicable federal, state, or contractual requirements and law.

Refer to the policy's applicable CPT/HCPCS/ICD lists when submitting authorization requests. Updated CPT codes include addition of 1012T (effective 03/01/2026).

Prior Authorization

Authorization should require baseline IOP and prior therapy documentation

Prior authorization (when required by the member's benefit plan) should include documentation of baseline intraocular pressure (IOP) and prior glaucoma therapies (medical and/or surgical) to support the medical necessity of the requested procedure. Authorization requests should also specify whether the procedure is being performed standalone or in combination with cataract surgery.

Clinical Background and Evidence Context

Glaucoma is a group of progressive optic neuropathies associated with elevated intraocular pressure that can lead to progressive visual field loss and optic nerve damage. Primary open‑angle glaucoma (POAG) is defined by optic nerve/RNFL structural abnormalities and reproducible visual field defects, and disease severity is commonly stratified as mild, moderate, severe, or indeterminate based on imaging and standard automated perimetry findings; these clinical descriptors provide the context for procedural selection and coverage considerations.

inv-06 (contextual): Evidence summaries included here also inform background discussion (overlap with coverage evidence)

Evidence summaries included here also inform background discussion (overlap with coverage evidence)

OMNI/combined canaloplasty evidence: Multicenter case series of OMNI combined with phaco reported medication‑free rates of 78% at 6 months and sustained >20% IOP reductions in most eyes at 12 months, though studies lacked control groups and had short follow‑up.

Gallardo et al. 6‑ and 12‑month series; limitations noted

EX‑PRESS long‑term outcomes: RCT extension data demonstrate sustained complete success rates favoring EX‑PRESS over trabeculectomy up to 5 years in the original trial population.

Definitions and Device/Procedure Glossary

Canaloplasty definition — surgical technique (inv-62)

DefinitionSurgical technique that viscodilates Schlemm's canal to restore aqueous outflow; may be performed by ab externo (outside-in) or ab interno (inside-out) approaches.

Ab externo descriptionAb externo uses conjunctival and scleral incisions with an intracanalicular suture to tension the trabecular meshwork and permanently open Schlemm's canal.

Ab interno descriptionAb interno inserts a microcatheter through a clear corneal or limbal incision across the trabecular meshwork into Schlemm's canal and dilates it with viscoelastic gel.

Cyclophotocoagulation (CPC) definition (inv-63)

DefinitionLaser ciliary body destruction (cyclophotocoagulation, CPC) that damages the ciliary epithelium to reduce aqueous humor secretion and lower IOP.

Policy Revision History and Changes

2026-03-01codes_update_and_archivalLatest

Updated list of applicable CPT codes to reflect annual edits; added CPT 1012T and archived previous policy version CS050KY.08.

2026-03-01billing_code_update_riskLatest

Policy history notes addition of CPT code 1012T which could affect billing if not used; providers should reference updated codes when submitting claims.

As noted elsewhere in the policy excerpts, several sections summarize evidence and procedural lists without explicitly labeling individual procedures as not medically necessary. The policy does, however, include an overarching statement that all other unlisted laser procedures are considered unproven and not medically necessary, and it reminds readers to review governing federal/state/contractual plan terms which may impose additional requirements beyond what is summarized here.

Policy Summary

PayerUnitedHealthcare

PolicyGlaucoma Surgical Treatments (for Kentucky Only)

Policy CodePolicy CS050KY.09

Change TypeUpdated applicable CPT codespolicy history entry 03/01/2026

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionWhen submitting claims or prior authorization requests, use the updated applicable code list (including 1012T) and document baseline IOP and prior therapy.

SourceLink

On This Page

XEN evidence: Systematic reviews and cohort studies report IOP reductions and medication decreases with XEN but most evidence is nonrandomized, with frequent need for postoperative interventions and variable follow‑up durations up to 5 years.

ECRI 2025 update; Buffault 2019

Laser peripheral iridotomy (LPI): A multicenter RCT in PACS (480 participants) showed prophylactic LPI reduced progression to PAC/PACG over 5 years (NNT = 22), supporting its prophylactic benefit in selected patients.

Baskaran et al. 2022

Laser iridoplasty (LPIp): Small RCTs and a Cochrane review show mixed results for LPIp; anterior chamber morphology may improve but consistent IOP lowering versus LPI alone is not established, and trials had small samples and risk of bias.

Qin 2023; Bayliss et al. 2021

Ab‑interno canaloplasty and combined canaloplasty/trabeculotomy (OMNI, Streamline): Case series and limited RCT interim reports show reductions in IOP and medication use when performed with phacoemulsification, but evidence is generally single‑arm, short follow‑up, and at risk of bias; comparative effectiveness versus established procedures is not well established.

Gallardo et al. case series; ECRI/Hayes assessments

Baseline IOP (including diurnal or washout values if available)
Number and type of prior topical/systemic IOP-lowering medications and prior laser or incisional glaucoma surgeries
Indication (glaucoma type and severity) and whether combined with phacoemulsification/cataract surgery

Prior Authorization

Prior authorization recommended for implantable devices

Prior authorization review is recommended for implantable glaucoma devices and aqueous shunts given device-specific indications, variable evidence, and potential for significant downstream costs and complications. Review should align with device FDA indications when applicable.

Examples: iStent, iStent inject, Hydrus (FDA-approved only with concurrent cataract surgery for mild–moderate OAG)
Aqueous shunts (e.g., Ahmed, Baerveldt, Molteno, Ex-PRESS, XEN) commonly used for refractory glaucomas — prior authorization recommended to document refractory status

Prior Authorization

Prior authorization recommended for novel canaloplasty/trabeculotomy systems

Prior authorization review is recommended for novel combined canaloplasty/trabeculotomy systems and other new ab interno devices (e.g., OMNI, Streamline, newer canaloplasty systems) because evidence is limited or primarily single-arm/low-quality; clinical reviewers should assess indication, baseline IOP, prior therapies, and available comparative evidence.

Document device name, FDA clearance/510(k)/PMA status, intended use (standalone vs with cataract), and supporting clinical evidence
If device is being used off-label (e.g., standalone when FDA clearance requires concurrent cataract), include rationale and supporting documentation

Note

Prior authorization not described in excerpt

No explicit prior authorization requirement is specified within some policy excerpts; payers and providers should verify member-specific benefit plan prior authorization rules.

Check the member's federal/state/contractual plan documents to determine if prior authorization is required for the requested procedure or device.

Documentation Required

Device FDA-indication alignment

Authorization and coverage determinations for device implantation should align with the device-specific FDA indications. Where the FDA indicates use only in combination with cataract surgery (e.g., iStent family, Hydrus), standalone use is off-label and should be justified in the clinical record if requested.

Document whether procedure is being performed concurrently with cataract surgery when seeking coverage for devices that have that FDA-limited indication.

Billing Rule

Applicable CPT codes updated

Applicable CPT codes have been updated — policy history reflects annual CPT edits including the addition of 1012T (03/01/2026). Providers should reference the current CPT list when submitting claims or prior authorization requests.

Update billing practices to include newly added CPT codes (e.g., 1012T) and any other annual edits noted in the policy history.

Billing Rule

Coding inclusion not guarantee of payment

Listing of codes in this policy is for reference and does not guarantee payment. Benefit coverage and payment determinations are governed by federal, state, and contractual plan terms and applicable law.

When codes conflict with contractual or state/federal requirements, those requirements govern coverage decisions.

Note

Surgical failure definition (pediatric cohort)

An operational definition of surgical failure used in pediatric cohorts (Huang et al.) is: (1) need for additional glaucoma filtering surgery; (2) deterioration to absence of light perception; or (3) IOP ≥ 21 mmHg on ocular hypotensive medications verified at two consecutive visits.

Use this definition when reviewers or auditors reference pediatric surgical outcomes reported in the literature.

Denial Risk

Evidence-based coverage risk

Evidence limitations and quality issues pose coverage and denial risks for some procedures and devices — low-quality, nonrandomized, short-term, or single-arm studies may be insufficient to establish superiority or long-term safety versus established procedures.

Examples of coverage risk: standalone KDB, XEN Gel Stent, and novel ab interno systems with primarily retrospective or single-arm evidence.
When evidence is insufficient, prior authorization reviewers may request additional documentation or may deny coverage as not medically necessary.

Denial Risk

Evidence quality risks for laser iridoplasty

Laser iridoplasty (LPIp) evidence is limited and of low quality; randomized trials show no clear IOP benefit over peripheral iridotomy alone. This lower-quality evidence increases the likelihood that coverage could be restricted or require additional justification.

Prior authorization or medical necessity review may request documentation of prior LPI, LPIp rationale, and alternative treatments considered.

Note

No operational authorization details present

Some sections of the policy do not provide operational authorization instructions (e.g., exact forms, timelines, or contact processes). Providers should follow the payer's standard prior authorization workflows and check the member's plan for specific operational requirements.

If requirements are unclear, contact the plan's provider services or utilization management for submission instructions and timeframes.

Denial Risk

Evidence insufficiency risk

Insufficient long-term comparative evidence for certain standalone procedures and devices (e.g., standalone KDB, some XEN studies, novel devices with short follow-up) increases risk that these interventions will be considered experimental/investigational and not covered.

When requesting authorization for such procedures, include the longest available follow-up data, rationale for use, and why established alternatives are not appropriate.

Documentation Required

Clinical documentation to support severity

Clinical documentation to support glaucoma severity should include optic disc/RNFL imaging, standard automated perimetry (SAP) visual field results, and classification of severity (mild, moderate, severe, indeterminate) per AAO definitions.

Attach recent optic disc/RNFL imaging reports and reliable SAP visual field tests when available.
If visual field testing is unreliable or not performed, document reason and include structural imaging and clinical rationale.

Documentation Required

Required outcome documentation

Required outcome documentation for prior authorization and post-procedure review should include baseline and follow-up IOP (including unmedicated diurnal IOP when reported), number of glaucoma medications, and any adverse events or additional glaucoma surgeries.

Document unmedicated DIOP reduction percentages (e.g., ≥ 20% DIOP reduction endpoints used in pivotal trials) when applicable
Report postoperative IOP values, medication counts, and any secondary surgical interventions.

Documentation Required