ModifiedColorado Rocky Mountain Health PlansPolicy 2026T0443LL

Glaucoma Surgical Treatments

Defines medical necessity and evidence for surgical and laser treatments for glaucoma for UnitedHealthcare Commercial and Individual Exchange benefit plans; covers pediatric and adult procedures and related devices.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyGlaucoma Surgical Treatments

Policy CodePolicy 2026T0443LL

Change TypeTemplate updateCPT list updated (1012T added)

Effective DateJanuary 1, 2026

Next Review Date

Key ActionObtain prior authorization when required by the member's benefit plan and document baseline IOP, medication burden, and device indication.

SourceLink

POLICY UPDATE CHANGES

Created shared policy version to support application to Oxford plan membership and updated applicable CPT codes; added 1012T.

01/01/2026Policy revision date

1012TCPT code added

84.2%OMNI 12‑mo ≥20% eyes

22.74%KDB meta‑analysis mean IOP↓

65.2%Pediatric goniotomy success (10yr)

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Coverage Criteria and Evidence Summary

Evidence summaries (no coverage rules in excerpt)

Evidence summaries (no coverage rules in excerpt) — The following summarizes key evidence by intervention and device class; no additional explicit payer coverage rules are provided in these excerpts.

Goniotomy or Trabeculotomy for Pediatric Glaucoma (Age 18 Years or Less): Huang et al. (2018) retrospective cohort (73 eyes) demonstrated that goniotomy, trabeculotomy, and filtering surgery maintained IOP <21 mmHg up to 10 years with estimated success probabilities varying by procedure (goniotomy ~65% at 10 and 20 years; trabeculotomy ~42% at 10 years; filtering surgery 91.7% at 10 years). Authors concluded all three procedures provide valuable long-term options for childhood glaucoma.

iStent and iStent inject: Kahale et al. (2023) systematic review/meta-analysis (10 comparative studies, 1453 eyes, mean follow-up 21.9 months) found greater IOP reduction and decreased medication use with combined iStent+phaco vs phaco alone; results showed heterogeneity and limited clinical implications. Samuelson et al. (2019a) pivotal multicenter RCT of iStent inject with phaco (n=386 treatment, n=118 control) showed greater proportions achieving ≥20% unmedicated IOP reduction and greater mean unmedicated DIOP reduction at 24 months, with favorable safety profiles.

Hydrus Microstent: Hu et al. (2022) network meta-analysis (6 RCTs, 1397 participants) suggested Hydrus and 2-iStent+phaco were more effective than phaco alone, with Hydrus possibly superior in ranking; limited by indirectness. ECRI evidence analysis (2019, updated 2024) found favorable but very low-quality evidence supporting Hydrus effectiveness up to five years and suggested need for additional RCTs. Fea et al. (2017b) retrospective series (92 eyes) reported significant IOP and medication reductions at 24 months but lacked a comparator.

Glaucoma Drainage Devices (EX-PRESS, Ahmed, Baerveldt, Molteno, XEN, Krupin-Denver): Multiple systematic reviews, RCTs, and meta-analyses report variable comparative outcomes. Sun et al. (2019) meta-analysis of EX-PRESS vs trabeculectomy (8 RCTs) found EX-PRESS had better IOP reduction percent at 12 months, higher complete success at 1 year, and fewer some complications. De Jong et al. (2011) 5-year extension reported higher complete success rates for Ex-PRESS vs trabeculectomy. Luo et al. (2023) systematic review of tube vs trabeculectomy (49 studies, 3795 eyes) found Ahmed and Ex-PRESS similar to trabeculectomy in IOP outcomes, while Baerveldt and XEN had worse IOP outcomes though success rates varied; evidence often nonrandomized and heterogeneous. Cochrane review (Tseng et al., 2017) concluded insufficient evidence to definitively compare aqueous shunts with trabeculectomy.

XEN Glaucoma Treatment System: ECRI (2025 update) reviewed 16 studies (one RCT, multiple observational) indicating XEN lowers IOP to clinically normal levels in many patients with effects up to ~5 years but most data to 12–24 months and high risk of bias. Chen et al. (2022) systematic review (56 studies, no RCTs) reported ~35% IOP reduction to mean ~15 mmHg and medication reduction but emphasized observational data limitations and need for further study. Grover et al. (2017b) single-arm prospective case series in refractory glaucoma (65 eyes) showed IOP and medication reductions with acceptable safety but lacked comparator.

Laser Trabeculoplasty (SLT): Gazzard et al. (2022) LIGHT RCT demonstrated that initial SLT provided better long-term disease control than eye drops at 6 years, with 69.8% of SLT eyes at or below target IOP without further intervention and lower progression in the SLT arm.

Laser Iridotomy/Iridectomy (LPI): Baskaran et al. (2022) multicenter RCT in primary angle-closure suspect (PACS) showed prophylactic LPI reduced development of PAC/PACG over 5 years versus control (NNT=22) with study limitations noted.

Laser Iridoplasty (LPIp): Qin et al. (2023) small RCT (32 participants) reported anterior chamber morphological improvements and IOP decreases post-LPIp with variable outcomes by energy/location; Bayliss et al. (2021) Cochrane review (4 RCTs, 252 participants) found insufficient evidence that argon LPIp provides additional IOP-lowering benefit over LPI and noted use of LPIp mainly as second-line for persistent appositional closure.

Laser Ciliary Destruction (Cyclodestructive procedures): Chen et al. (2019) Cochrane review (5 trials, 330 eyes) concluded evidence is inconclusive comparing cyclodestructive procedures to other treatments or among cyclodestructive modalities; common adverse events included hypotony and phthisis bulbi and larger RCTs needed.

Combined Canaloplasty (Ab Interno) and Trabeculotomy (e.g., OMNI, Streamline) for Adults: Single-arm and case series (GEMINI/Gallardo and others; total ~137–128 patients in studies) report substantial mean IOP reductions, high medication-free rates (e.g., 78–84% medication-free at 6–12 months), and favorable safety with transient hyphema and IOP spikes as common AEs; limitations include lack of randomized comparators and short follow-up.

Goniotomy/Trabeculotomy for Adults (KDB, GATT, KDB vs iStent comparisons): Systematic reviews and RCTs show mixed results. Radwan et al. (2024) meta-analysis of KDB+phaco (26 studies) found greater IOP and medication reduction versus phaco alone but with high heterogeneity. Ventura-Abreu et al. (2021) small RCT (n=42) found no significant additional benefit of KDB+phaco vs phaco alone at 12 months. Falkenberry et al. (2020) RCT comparing KDB+phaco vs iStent+phaco reported both reduced IOP and medication use, with more KDB eyes meeting composite outcomes though some analyses were post hoc. Retrospective comparative and observational studies (ElMallah et al., Dorairaj et al., Grover, Sieck) generally report IOP and medication reductions with KDB, GATT, and other trabeculotomy procedures but are limited by nonrandomized designs, baseline differences, and follow-up duration.

Other Laser Procedures (ELT, FLT, OCT-guided laser trabeculotomy): Evidence is limited. FLIGHT (Nagy et al., 2023) single-arm prospective trial (18 eyes) reported favorable initial safety and substantial mean IOP reduction at 24 months in a small cohort; Hayes (2024) and other reviews note insufficient peer-reviewed evidence to fully assess OCT-guided laser trabeculotomy and similar novel laser approaches. These treatments are not FDA-approved for glaucoma in the US.

Evidence quality and limitations: Across device classes and procedures, RCT data exist for some interventions (e.g., iStent inject pivotal RCT; Hydrus RCTs included in systematic reviews; SLT LIGHT trial; select RCTs for drainage devices), but much of the literature comprises nonrandomized observational studies, single-arm case series, or retrospective analyses with heterogeneity in populations, baseline IOP, device generations, outcome definitions, and follow-up duration. Many studies lack washout, have limited long-term follow-up, and vary in risk of bias; additional well-designed RCTs and comparative effectiveness studies with longer follow-up are frequently recommended.

Note: The excerpts did not include additional explicit coverage criteria beyond statements that certain procedures are proven and medically necessary when specified and that most other laser procedures lack sufficient evidence.

Applicable CPT/HCPCS Codes and Coding Notes

Applicable CPT/HCPCS Codes (group 1)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 16

1/2

Applicable CPT/HCPCS Codes (group 2)mixed

66710	Ciliary body destruction; cyclophotocoagulation, transscleral.
66711	Ciliary body destruction; cyclophotocoagulation, endoscopic, without concomitant removal of crystalline lens.
66761	Iridotomy/iridectomy by laser surgery (e.g., for glaucoma) (per session).
66762	Iridoplasty by photocoagulation (1 or more sessions) (e.g., for improvement of vision, for widening of anterior chamber angle).
66989	Extracapsular cataract removal with insertion of intraocular lens prosthesis...; with insertion of intraocular anterior segment aqueous drainage device, internal approach, one or more.
66991	Extracapsular cataract removal with insertion of intraocular lens prosthesis...; with insertion of intraocular anterior segment aqueous drainage device, internal approach, one or more.
L8612	Aqueous shunt

No codes listedmixed

No codes listed

Covered CPT CodesCPT

No codes listed

Device PMN/PMA Identifiers mentionedmixed

K062259	iTRACK Canaloplasty Ophthalmic Microcannula (FDA PMN)
K211680	Streamline Surgical System (Streamline Viscoelastic Injector)
K030350	ExPRESS Mini Glaucoma Shunt (501(k) approval)
P170043	iStent inject PMA identifier

Applicable CPT codes (updated)CPT

1012T

CPT code added per applicable codes update (description as in policy code list).

Applicable CPT Codes (updated)CPT

1012T

added to list of applicable CPT codes

MIGS efficacy threshold

MIGS efficacy thresholdAt least 20% intraocular pressure (IOP) reduction or reduction of at least one glaucoma medication

Intended patient severityTypically used for mild to moderate glaucoma; not appropriate for patients requiring very low IOP targets (advanced disease)

Common combinationOften performed concurrently with phacoemulsification (cataract surgery)

Examples of approachesTrabecular bypass stents, tissue-excising goniotomy, viscodilation (ABiC), suprachoroidal/scleral shunts, cyclodestruction

IOP target examples

Provider Actions, Authorization and Documentation

Billing Rule

Applicable Codes Referenced

Applicable procedure and diagnosis codes are listed for reference; inclusion does not guarantee coverage or payment. Providers should verify member-specific benefit documents and obtain prior authorization when required by the member’s plan.

Affected CPT/HCPCS examples include: 0253T, 0449T-0450T, 0474T, 0621T-0622T, 0671T, 0730T, 1012T, 65820, 65855, 66174-66175, 66179-66183, 66710-66711, 66761-66762, 66989-66991, L8612 (HCPCS)

Prior Authorization

Prior Authorization: No Requirements Stated in Policy Text

No explicit prior authorization requirements are stated in this policy excerpt. However, prior authorization processes may still apply per member-specific plan rules.

Background and Definitions

Glaucoma is a group of progressive optic neuropathies often associated with elevated intraocular pressure (IOP) that can lead to visual field loss. Management strategies include medical therapy to lower IOP, laser procedures (such as selective laser trabeculoplasty and peripheral iridotomy), and surgical approaches ranging from angle‑based procedures (goniotomy, trabeculotomy, GATT) and canaloplasty to traditional filtration surgery and implantation of glaucoma drainage devices. Treatment selection is individualized based on age, glaucoma type and severity, IOP target, prior treatments, and patient‑specific considerations.

Canaloplasty

DefinitionCanaloplasty: viscodilation of Schlemm's canal to restore outflow, performed via ab externo or ab interno approaches

Ab externo techniqueMicrocatheter inserted through conjunctival and scleral cuts with an intracanalicular suture to tension trabecular meshwork

Ab interno techniqueMicrocatheter inserted via corneal or limbal incision through the trabecular meshwork into Schlemm's canal and viscodilated

Goniotomy / Trabeculotomy / GATT

Policy Revision History

01/01/2026revisionLatest

Template update creating a shared policy version for application to Oxford plan membership; applicable CPT codes updated and CPT 1012T added; prior policy versions 2025T0443KK and VISION 023.33 archived.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyGlaucoma Surgical Treatments

Policy CodePolicy 2026T0443LL

Change TypeTemplate updateCPT list updated (1012T added)

Effective DateJanuary 1, 2026

Next Review Date

Key ActionObtain prior authorization when required by the member's benefit plan and document baseline IOP, medication burden, and device indication.

SourceLink

On This Page

Complete success examplesIOP ≤ 18 mmHg without antiglaucoma medication (example reported in De Jong extension and related trials)

Stringent target exampleIOP ≤ 15 mmHg reported as a more stringent endpoint in some trials

SLT trial targetLIGHT trial: 69.8% of SLT eyes remained at or below the trial-specific target IOP at 6 years

Coding key_value placeholder (no summary)

Coding summary

Prior Authorization

Prior Authorization Recommended for Combined OMNI/Streamline Procedures

For combined canaloplasty (ab interno) plus trabeculotomy procedures (e.g., OMNI Surgical System, Streamline Surgical System) performed with phacoemulsification, prior authorization may be appropriate given evolving evidence and device-specific considerations. Document clinical indication and prior treatment history to support authorization.

Device examples: OMNI Surgical System, Streamline Surgical System (FDA product pages referenced)
Document baseline and follow-up IOP, number of glaucoma medications, gonioscopy findings, age, and prior glaucoma surgeries

Documentation Required

Device Indication and Authorization

Use of FDA-approved devices should be documented to support authorization decisions. When a device is FDA-approved only for use in combination with cataract surgery, standalone use is off-label and may increase risk of denial unless well justified.

Document device name, model/K number, and FDA indication (e.g., iStent, iStent inject, Hydrus, XEN, ExPRESS, OMNI, Streamline)
Examples of off-label situations: standalone iStent inject (approved only with cataract surgery)

Billing Rule

Updated Applicable Codes (May Affect Authorization)

Applicable CPT codes were updated in the policy history (01/01/2026); code 1012T was added. Providers should confirm whether newly added codes require plan-level prior authorization or affect billing workflows.

Newly added: 1012T (motorized ab interno trephination/trabeculostomy)
Verify prior authorization and billing applicability for newly added codes with the payer

Note

No Explicit Authorization or Denial Triggers Specified

No explicit authorization triggers, step therapy requirements, or denial conditions are defined in this excerpt. Coverage determinations should rely on member-specific benefit documents and applicable mandates.

Denial Risk

Cyclodestruction: Evidence Insufficiency and Denial Risk

Evidence for cyclodestructive procedures (cyclophotocoagulation) is inconclusive. Insufficient high-quality data may lead to denial or limited coverage for some cyclodestructive techniques; document rationale when requesting coverage.

Commonly reported adverse events include hypotony and phthisis bulbi
If pursued, include prior treatments tried and why alternative surgeries are unsuitable

Denial Risk

Off-Label Device Use: Increased Denial Risk

Off-label use of devices (for example, standalone use of devices approved only with cataract surgery) increases risk of claim denial. Provide documentation of medical necessity and rationale when requesting authorization for off-label use.

Examples: iStent inject — FDA approved only in conjunction with cataract surgery; standalone implantation is off-label
Include prior treatment history, objective measures, and why on-label options are unsuitable

Note

No Explicit Denial Triggers Present in Excerpt

No specific denial triggers are enumerated in this policy excerpt. Nonetheless, lack of documentation of FDA indication, absence of supporting clinical data, or use that conflicts with member benefit terms may result in denial.

Documentation Required

Required Clinical Data to Support Authorization and Claims

Studies and case series commonly report essential clinical data that should be included when requesting authorization or documenting procedures: baseline and follow-up IOP measurements, number and type of IOP-lowering medications, gonioscopy findings, age, prior glaucoma surgeries, visual acuity, and follow-up duration.

Baseline and post-procedure IOP (including washout values when available)
Number and type of glaucoma medications pre- and post-procedure
Gonioscopy/anterior chamber angle assessment
Document prior glaucoma surgeries and intended surgical target/goal
Follow-up intervals and outcome measurements (e.g., medication-free status, % IOP reduction)

Documentation Required

Reported Clinical Outcomes to Document

Outcomes typically reported and relevant to coverage decisions include IOP reduction (absolute and %), change in number of glaucoma medications, rates of medication-free status, adverse events (e.g., hyphema, IOP spikes), and need for secondary surgical interventions. Include these outcomes in post-procedure documentation and authorization requests.

IOP reduction and percent change from baseline
Change in number of glaucoma medications and medication-free rates
Adverse events and secondary surgical intervention rates
Duration of follow-up and sustainability of effect

Documentation Required

Required Clinical Baseline Data

Required baseline clinical data commonly requested to determine medical necessity include baseline IOP, number of IOP-lowering medications, type and severity of glaucoma, prior surgical history, and the intended surgical target or goal.

Baseline IOP (including diurnal and washout values if available)
Baseline number and type of glaucoma medications
Glaucoma diagnosis and stage (e.g., mild, moderate POAG)
Prior glaucoma surgeries and their outcomes
Document treatment goal (e.g., medication reduction, target IOP)

Documentation Required

Document Device Approvals and FDA References

When applicable, document the device approval information and FDA reference (device name, model number, K/PMA number) to support coverage and authorization.

Examples: iStent (GTS100) K-number and approval date; iStent inject PMA P170043; Hydrus P170034; XEN K161457; ExPRESS K030350; OMNI and Streamline FDA product pages (chunks 107-110)

Note

Check Member-Specific Plan Before Applying Policy

Always verify member-specific benefit plan language and applicable federal or state mandates before rendering coverage decisions. In the event of conflict, the member’s benefit document governs.

Check the member-specific benefit plan and any relevant mandates prior to authorization or claims submission
Contact the payer for plan-specific prior authorization requirements

DefinitionGoniotomy/Trabeculotomy: internal incision or excision of the trabecular meshwork to create or enlarge an opening into Schlemm's canal

GATTGonioscopy-assisted transluminal trabeculotomy (GATT) is a circumferential (360°) ab interno trabeculotomy using an illuminated microcatheter or suture

PurposeReduce resistance to aqueous outflow by removing or incising trabecular tissue

MIGS

DefinitionMIGS: minimally invasive glaucoma surgeries, typically performed via an ab interno approach and often combined with cataract extraction (phacoemulsification)

Clinical profileLower procedural risk than traditional filtering surgery but generally smaller IOP reductions

Typical candidatesAdults with mild to moderate open-angle glaucoma seeking modest IOP and/or medication reduction

Glaucoma drainage devices

DefinitionGlaucoma drainage devices (GDDs): implants that shunt aqueous humor to a bleb or reservoir (extraocular plate or subconjunctival space) to lower IOP

ExamplesExPRESS Mini Glaucoma Shunt, Molteno implant, Baerveldt tube shunt, Ahmed glaucoma valve, Krupin-Denver valve, XEN Gel Stent

Indication contextUsed for refractory glaucoma when conventional medical/surgical treatments have failed or are inappropriate

Surgical failure (Huang et al.)

Study definitionSurgical failure (Huang et al.): 1) additional glaucoma filtering surgery performed; 2) visual acuity deteriorated to absence of light perception; or 3) IOP ≥ 21 mmHg with ocular hypotensive medications verified at two consecutive visits

ContextApplied in long-term pediatric cohort assessing goniotomy, trabeculotomy, and filtering procedures

Complete success / Qualified success / Failure

Complete successTarget endpoint IOP without antiglaucoma medication (trial-specific targets; e.g., IOP ≤18 mmHg in some studies)

Qualified successTarget endpoint IOP with or without antiglaucoma medication

FailureNot meeting target IOP despite therapy or other failure definitions as used in individual studies

Complete success (in studies)

DefinitionComplete success (studies): achieving the trial-specified target IOP without antiglaucoma medications (example: IOP ≤18 mmHg without meds reported in de Jong/extension trials)

UsageUsed as a primary outcome in RCTs and extensions comparing devices vs trabeculectomy or other interventions

ReportingComplete success rates often reported at 12 months and longer-term extensions (eg, 1–5 years)

Qualified success (in studies)

DefinitionQualified success (studies): meeting the trial-specified target IOP with or without antiglaucoma medications

InterpretationOften reported alongside complete success to reflect outcomes achievable with adjunctive medical therapy

Primary angle closure (PAC)

DefinitionPrimary angle closure (PAC): presence of peripheral anterior synechiae (PAS), intraocular pressure > 21 mmHg, or acute angle closure

Clinical implicationUsed as an endpoint definition in LPI trials assessing progression from PACS to PAC/PACG

Ab-interno canaloplasty (ABiC)

DefinitionAb-interno canaloplasty (ABiC): minimally invasive microcatheterization and viscodilation of Schlemm's canal performed from inside the eye

Combination useMay be performed standalone or combined with cataract surgery; aims to dilate canal and improve distal outflow

OMNI surgical system

Device descriptionOMNI Surgical System: integrated instrument to perform ab interno viscodilation of Schlemm's canal and 360° trabeculotomy

Indications in studiesUsed standalone or combined with phacoemulsification in clinical studies for mild-moderate OAG

KDB (Kahook Dual Blade) goniotomy

ProcedureKahook Dual Blade (KDB) goniotomy: excisional goniotomy using a dual-blade instrument to remove trabecular meshwork tissue

Clinical usePerformed standalone or combined with phacoemulsification; reported in randomized and comparative studies

Trabectome

ProcedureTrabectome: electrosurgical ab interno trabecular ablation platform using a single-use handpiece and electrode tip to ablate trabecular meshwork

EvidenceLow-quality evidence from nonrandomized studies; additional RCTs needed to compare with other MIGS or conventional surgery

iStent / iStent inject identifiers

iStent / iStent injectTrabecular micro‑bypass stent systems FDA‑approved for use in combination with cataract surgery to reduce IOP in adults with mild to moderate OAG

Regulatory noteiStent inject PMA (P170043) approved only for use with cataract surgery; standalone use is off‑label

OMNI Surgical System device entry

Device entryOMNI Surgical System: handheld device to microcatheterize and viscodilate Schlemm's canal and perform trabeculotomy (FDA product codes referenced)

Regulatory contextDescribed in FDA informational section; Class II device references and product codes cited

FLIGHT / FLT / ELT / OCT-guided laser trabeculotomy

DescriptionFLIGHT/FLT/ELT/OCT‑guided laser trabeculotomy: laser‑based trabeculotomy techniques under investigation with limited published evidence

Regulatory statusNot currently FDA‑approved for glaucoma treatment in the United States

Evidence noteEarly single-arm or small trials report IOP reductions but larger randomized studies are lacking

iStent and iStent inject

DefinitioniStent and iStent inject: trabecular micro‑bypass stent systems approved for use with cataract surgery to reduce IOP in adults with mild to moderate OAG

Off‑label cautionStandalone use of iStent inject is considered off‑label and may risk denial if billed outside approved indication

Hydrus and XEN

HydrusHydrus Microstent: microstent approved for use with cataract surgery for reduction of IOP in adults with mild to moderate POAG

XENXEN Gel Stent: gelatin tube implanted into the subconjunctival space for management of glaucoma; approved device for IOP reduction

ContextBoth devices represent microstent strategies for lowering IOP via trabecular or subconjunctival pathways

Eagle laser

DeviceEagle laser: Q‑switched, 532 nm Nd:YAG laser intended for selective laser trabeculoplasty (SLT)

Approval dateApproved Dec 12, 2023 (K230722) per FDA section

Xen Gel Stent (manufacturer reference)

Manufacturer referenceXen® Gel Stent referenced (manufacturer website cited in references)

Reference listingManufacturer website cited in policy references for device information

Kahook Dual Blade procedure (trial cited)

Procedure referencedKahook Dual Blade procedure: ab interno trabeculectomy with KDB described and cited in randomized clinical study references

EvidenceRandomized controlled clinical study (Ventura‑Abreu et al. 2021) and meta‑analyses cited in references and evidence sections