CurrentAetnaPolicy 0457

Dry Eyes

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Clinical policy governing medical necessity and investigational status of diagnostic tests and interventions for dry eye syndrome for Aetna members. Affects providers submitting claims for treatments such as punctal plugs, punctoplasty, tear osmolarity testing, and related procedures.

Policy Summary

PayerAetna

PolicyDry Eyes

Policy CodePolicy 0457

Change TypeNone (no material changes)

Effective DateN/A

Last ReviewJul 11, 2023

Next Review DateN/A

Key ActionDocument diagnosis of severe dry eyes with objective evidence (e.g., Schirmer test, tear break-up time, or ocular surface staining) before submitting for punctal procedures.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

several (20+)listed experimental/investigational interventions

305 mOsm/Ltear osmolarity cut-off cited

40-65%InflammaDry-positive rate reported

68760,68761,68801,83861example CPT codes listed as covered if criteria met

A4262,A4263example HCPCS codes for punctal implants

Coverage Criteria and Policy Determinations

Evidence summaries (no coverage rules present)

Evidence summaries (no coverage rules present) — aggregated evidence summaries without explicit coverage nodes.

Tear Film Biomarkers (e.g., Goblet Cell-Specific MUC5AC and Interleukin-8): Akpek et al (2020) conducted a prospective observational case-control study (n=62) assessing tear MUC5AC and cytokines for distinguishing Sjögren versus non-Sjögren dry eye; findings showed reduced MUC5AC and higher IL-8 associated with Sjögren diagnosis, suggesting potential diagnostic value but not yet established for routine clinical use.

InflammaDry (MMP-9): Multiple sources provide mixed evidence. Sambursky (2016) retrospective chart review (n=100) reported that InflammaDry identified elevated MMP-9 in 60% of symptomatic patients and changes in treatment management with symptomatic improvement at ~90 days, but study limitations include retrospective design and lack of control. Dohlman et al (2016) and AAO (2018) note that point-of-care MMP-9 testing can aid diagnosis and disease monitoring, but it does not differentiate dry eye from other inflammatory ocular surface diseases.

Tear Osmolarity Measurement: Devices that measure tear osmolarity are commercially available and cited as objective parameters to stage DED severity in guideline-based management (Foulks et al, 2015); evidence supports use as part of comprehensive assessment but no single gold-standard diagnostic test exists.

InflammaDry Guideline Context: The 2015 consensus guideline for Sjögren-associated DED (Foulks et al) recommended use of objective parameters including tear osmolarity and measures of ocular surface inflammation in staging disease, but did not specifically endorse routine MMP-9 measurement.

Intense Pulsed Light (IPL): Systematic reviews and RCT evidence are limited and of low/very low certainty. Small RCTs (total 3 trials, 114 adults) showed inconsistent effects on symptoms; a 2023 meta-analysis (Qin et al) including many studies reported improvements in symptom scores and TBUT but heterogeneity, risk of bias, variable protocols, and incomplete adverse event reporting limit conclusions. Overall, evidence for IPL in meibomian-gland dysfunction–related DED is scarce/low certainty and clinical value remains uncertain.

Etanercept and Systemic Cytokine Therapy: Systematic review (Shih et al, 2017) found that subcutaneous etanercept did not improve dry eye outcomes compared to placebo; authors noted systemic cytokine therapies have not produced encouraging ocular results and highlighted need for biomarker-informed trials.

Minor Salivary Gland Autotransplantation: Case series and uncontrolled reports (Wakamatsu et al, 2017) describe symptomatic and objective improvements in severe cases, but major clinical reviews and UpToDate do not list this as an established therapy; evidence limited to small, nonrandomized studies.

Botulinum Toxin: Small, short-term studies suggest potential benefit for intractable DED, but data are preliminary (small n, short follow-up) and UpToDate does not mention botulinum toxin as an established option.

Cross-Linked Hyaluronic Acid Gel Occlusive Devices: Single-arm, open-label studies report some positive findings but lack control groups; UpToDate does not list as standard therapy and evidence is insufficient.

Moxibustion, Acupuncture, Auricular Acupressure: Systematic reviews and meta-analyses report some positive signals (e.g., acupuncture meta-analysis of 21 RCTs; auricular acupressure meta-analysis of 7 RCTs) showing improvements in TBUT, Schirmer, or symptom scores versus artificial tears, but studies vary in quality, and reviewers conclude that higher-quality RCTs are needed to confirm benefits.

Androgen and Hormone Replacement Therapies: Systematic reviews (Wang & Deng 2020; Dang et al 2020) report mixed or transient findings; some short-term improvements noted but overall evidence is inconclusive and major guidance documents (UpToDate, AAO PPP) do not endorse ART/HRT as established management.

Topical Omega-3 Fatty Acid Eyedrops: Limited human studies (n small) suggest potential improvement in ocular surface staining and TBUT, but evidence base is sparse; by contrast, large RCTs of oral omega-3 supplementation showed no benefit over placebo.

Rituximab and Other Systemic Immunomodulators: RCT evidence (Devauchelle-Pensec et al, 2014) showed no significant benefit of rituximab for primary Sjögren's syndrome at 24 weeks for primary endpoints, although some early symptomatic improvements were observed; overall efficacy for dry eye is not established.

Novel Biologic/Regenerative Approaches (e.g., mesenchymal stem cells, TEMPO-oxidized sacchachitin nanofibers with PRP): Early-stage and heterogeneous reports exist but robust RCT evidence is lacking; clinical effectiveness remains unproven.

Clinical Implication: Across multiple modalities, evidence ranges from preliminary/low-certainty positive signals to negative large trials (e.g., oral omega-3). Several biomarkers and point-of-care tests may aid assessment or phenotyping of DED (tear osmolarity, MMP-9, tear MUC5AC), but none constitute a definitive standalone diagnostic standard. Many novel interventions require higher-quality randomized trials with standardized outcomes and safety reporting before they can be considered established therapies.

Coding — Covered and Not Covered Codes; Clinical Thresholds

CPT codes covered if selection criteria are metCPTCovered

68760	Closure of the lacrimal punctum; by thermocauterization, ligation, or laser surgery.
68761	Closure of the lacrimal punctum; by plug, each.
68801	Dilation of lacrimal punctum, with or without irrigation.
83861	Microfluidic analysis utilizing an integrated collection and analysis device, tear osmolarity.

HCPCS codes covered if selection criteria are metHCPCSCovered

A4262	Temporary, absorbable lacrimal duct implant, each.
A4263	Permanent, long-term, nondissolvable lacrimal duct implant, each.

CPT codes not covered for indications listedCPTNot Covered

0232T	Injection(s), platelet rich plasma, any site, including image guidance, harvesting and preparation when performed [combined with TEMPO-oxidized sacchachitin nanofibers (TOSCNFs)].
0330T	Tear film imaging, unilateral or bilateral, with interpretation and report.
83516	Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method.

HCPCS/J-codes not covered for indications listedmixedNot Covered

J0585	Botulinum toxin type A, per unit [Botox].
J9312	Injection, rituximab, 10 mg.
J1438	Injection, etanercept, 25 mg.

ICD-10 codes covered if selection criteria are metICD-10Covered

H04.121 - H04.129	Dry eye syndrome.
H04.561 - H04.569	Stenosis of lacrimal punctum.
H11.141 - H11.149	Conjunctival xerosis, unspecified.
H16.221 - H16.229	Keratoconjunctivitis sicca, not specified as Sjögren's.
M35.0 - M35.09	Sicca syndrome [Sjögren].

No CPT/HCPCS/ICD codes specified in this excerptmixed

No codes listed

inv-25: Schirmer test threshold — wetting < 5 mm in 5 minutes considered abnormal.

Schirmer test thresholdWetting < 5 mm in 5 minutes is considered abnormal.

Test methodSterile filter paper placed in the lateral third of the lower eyelid; measured after 5 minutes.

PurposeMeasures tear production (basal tear secretion).

inv-26: Tear break-up time threshold — TFBUT < 10 seconds considered abnormal.

TFBUT abnormal thresholdBreak-up time < 10 seconds is considered abnormal.

Test descriptionMeasured after instillation of fluorescein; eye examined under blue light to observe tear film break-up.

Clinical relevanceProvides global assessment of lacrimal functional unit and tear exchange on ocular surface.

inv-27: Tear osmolarity thresholds — 305 mOsm/L dry; 309 moderate; 318 severe (summary entry).

Tear osmolarity — dry305 mOsm/L (cut-off for dry eye).

Tear osmolarity — moderate309 mOsm/L (cut-off for moderate dry eye).

Tear osmolarity — severe318 mOsm/L (cut-off for severe dry eye).

inv-28: Tear osmolarity cut-offs — 305/309/318 mOsm/L mapping to dry/moderate/severe.

305 mOsm/LInterpreted as dry eye (cut-off).

309 mOsm/LInterpreted as moderate dry eye (cut-off).

318 mOsm/LInterpreted as severe dry eye (cut-off).

inv-29: InflammaDry positive threshold — >= 40 ng/mL MMP-9.

InflammaDry positive threshold>= 40 ng/mL MMP-9 (qualitative positive).

Test typePoint-of-care immunoassay detecting tear MMP-9 as marker of ocular surface inflammation.

Clinical useCan be used as diagnostic aid and to assess change in disease state but does not differentiate DED from other inflammatory ocular surface diseases.

inv-30: Tear osmolarity cutoff referenced elsewhere — 308 mOsm/L mention.

Alternate tear osmolarity cutoff mentioned308 mOsm/L referenced in cohort/classification analysis.

ContextUsed as a classification cutoff (e.g., >308 mOsm/L) in some studies for diagnostic grouping.

Relation to other cut-offsClose to 305–309 mOsm/L diagnostic thresholds cited for dry/moderate DED.

inv-31: Study follow-up range — example clinical study follow-up 45 days to 9 months.

Study follow-up range (example)Follow-up periods reported ranged from 45 days to 9 months in included IPL trials.

Study typesRandomized controlled trials and interventional studies with variable follow-up durations.

ImplicationFollow-up intervals in DED device trials vary widely; use ranges when comparing outcomes across studies.

Provider Actions, Authorization, and Documentation Requirements

Prior Authorization

Prior authorization for selected CPT/HCPCS

Prior authorization required for selected CPT/HCPCS when selection criteria are met. Affected codes include: CPT 68760 (closure of lacrimal punctum by thermocauterization/ligation/laser), 68761 (closure by plug, each), 68801 (dilation of lacrimal punctum), 83861 (tear osmolarity microfluidic analysis), and HCPCS A4262 (temporary absorbable lacrimal duct implant) and A4263 (permanent long-term nondissolvable lacrimal duct implant). Providers should verify plan-level PA processes and submit objective documentation (see documentation callout) with PA requests.

Prior authorization may be required for CPT: 68760, 68761, 68801, 83861
HCPCS: A4262, A4263

Note

Prior authorization not specified / None specified

No specific prior authorization requirement is stated for many treatments and devices discussed in this policy excerpt. Several sections and device/study summaries do not specify PA requirements — e.g., thermal pulsation systems, IPL, cross-linked hyaluronic acid gel occlusive devices, and autologous serum (study-level evidence only). Verify member benefits and medical necessity criteria prior to scheduling.

Thermal pulsation: PA not specified in excerpts
Intense pulsed light (IPL): PA not specified in excerpts
Cross-linked HA gel occlusive device: PA not specified (study-level evidence)
Autologous serum tears: policy lists as medically necessary when criteria met; PA not specified in these excerpts

Documentation Required

Punctal occlusion treatment indication and conservative therapy prerequisite

Punctal occlusion (temporary or semi-permanent plugs, punctoplasty) is indicated only for moderately severe to severe dry eye that is refractory to conservative management. Conservative measures should be tried first, including at least a 2-week trial of artificial tears, ophthalmic cyclosporine where indicated, and adjustment of medications that may contribute to dry eye. Document objective evidence of lacrimal gland deficiency (e.g., Schirmer test or tear break-up time) or corneal compromise on slit-lamp exam.

Indication: moderately severe to severe dry eye not controlled with conservative measures
Conservative trial: ≥2 weeks of artificial tears, trial of ophthalmic cyclosporine where indicated, medication adjustment
Objective evidence required: Schirmer test, TBUT, ocular surface dye staining or slit-lamp evidence of corneal decompensation

Documentation Required

Required clinical documentation and evaluation guidance

Required clinical documentation for procedural therapies: providers should document the diagnosis of severe dry eyes, symptom severity, and objective test results (Schirmer, TBUT, ocular surface staining, tear osmolarity where available). For punctal procedures, failure to document these elements or corneal compromise may result in non-coverage. When submitting for PA, include prior conservative treatments tried and their duration.

Documented diagnosis of severe dry eye (keratoconjunctivitis sicca)
Objective tests: Schirmer test (wetting <5 mm/5 min abnormal), TBUT, ocular surface staining (rose bengal, fluorescein, lissamine green)
Conservative therapy documentation: duration and response to artificial tears, cyclosporine, medication adjustments
Include rationale when autologous serum or procedural therapy is requested

Note

Autologous serum — evidence quality note

Autologous serum tears: evidence quality is variable with small RCTs and heterogeneity in methods and outcomes. Trials show inconsistent benefit for symptoms and TBUT and no clear benefit on Schirmer, ocular surface staining, or impression cytology. When used, document trial details, prior therapies, and rationale given limited high-quality evidence.

Evidence: small RCTs (n totals small), variable risk of bias, inconsistent outcomes
Documentation: trial protocol, concentration used, duration of therapy, prior treatments and response

Step Therapy

Treatment escalation and therapeutic sequencing (informational)

Therapeutic sequencing: escalate treatment from conservative measures (environmental/lid hygiene, OTC lubricants, adjust exacerbating medications) to anti-inflammatory agents (topical corticosteroids, cyclosporine, lifitegrast) and consider procedural options (punctal occlusion, thermal pulsation, IPL, tarsorrhaphy) if refractory. No formal step-therapy rules or mandatory sequencing were specified in this excerpt; thermal pulsation and IPL are presented as options when conventional measures fail.

Start: environmental modifications, lubricants, warm compresses, lid hygiene
Next: prescription anti-inflammatory agents (e.g., cyclosporine, lifitegrast)
Procedural options: punctal occlusion, thermal pulsation (eg LipiFlow), IPL, tarsorrhaphy for refractory cases
No explicit step-therapy enforcement found in policy excerpts

Documentation Required

Reported clinical measures

Reported clinical measures used in studies and recommended for assessment: TBUT, Schirmer test, ocular surface staining (fluorescein, rose bengal, lissamine green), tear osmolarity, MMP-9 (InflammaDry), tear meniscus height, corneal staining scores, and validated symptom questionnaires (OSDI, SPEED). Include these objective measures in documentation when available.

Objective tests: TBUT, Schirmer, ocular surface staining
Biomarkers/assays: tear osmolarity (83861), MMP-9 (InflammaDry), tear MUC5AC/IL-8 in research settings
Symptom scales: OSDI, SPEED

Note

Policy history and review dates

Policy history and review dates are provided in the document header. Effective date listed: 10/04/2000; last review: 07/11/2023; next review scheduled: 05/09/2024. Use these dates to confirm currency of policy guidance and any subsequent updates that may affect authorization or coverage.

Effective: 10/04/2000
Last Review: 07/11/2023
Next Review: 05/09/2024

Background and Context

Background: Dry eye syndrome is a chronic disorder of the ocular surface characterized by tear film instability, ocular surface inflammation, and symptoms of dryness and irritation. It results from decreased tear production or excessive evaporative loss and ranges in severity from mild symptoms to severe disease with corneal damage and vision risk. Common objective assessments referenced in the policy include the Schirmer test, ocular surface staining (rose bengal, lissamine green, fluorescein), and tear film break-up time (TFBUT), and the policy also highlights tear osmolarity as a key diagnostic marker.

Definitions and Clinical Measures

inv-62: Schirmer test definition and threshold.

DefinitionSchirmer test: tear production measure using sterile filter paper placed in the lower eyelid.

ThresholdWetting < 5 mm in 5 minutes is considered abnormal.

Clinical useObjective assessment of lacrimal gland tear production; often performed by ophthalmologists.

inv-63: Ocular surface staining (rose bengal, lissamine green, fluorescein) definition.

DefinitionOcular surface staining uses dyes (rose bengal, lissamine green, fluorescein) to assess devitalized conjunctival and corneal tissue.

TechniquesRose bengal, lissamine green, or fluorescein are instilled and staining patterns scored by slit-lamp examination.

Clinical interpretationExposure-zone corneal and bulbar conjunctival staining is typical of aqueous tear deficiency.

inv-64: Tear film break-up time (TFBUT) definition and abnormal threshold.

DefinitionTear film break-up time (TFBUT): measure of tear film stability after fluorescein instillation.

Abnormal thresholdBreak-up times less than 10 seconds are considered abnormal.

MethodAfter fluorescein, eye is examined under blue light and time to tear film break-up is recorded.

inv-65: Tear osmolarity — definition and cited cut-offs as key marker of dry eye disease.

DefinitionTear osmolarity: measurement of salt concentration in tear fluid; key marker of dry eye disease.

Cited cut-offs305 mOsm/L (dry), 309 mOsm/L (moderate), 318 mOsm/L (severe).

Clinical roleOsmolarity has highest correlation to disease severity among common tests and is suitable for clinical use.

inv-66: Punctal plugs / punctal occlusion — definition of device types (temporary, semi-permanent, permanent).

DefinitionPunctal plugs/occlusion: devices or procedures that occlude lacrimal puncta to slow tear drainage (temporary, semi-permanent, permanent).

Device typesTemporary: dissolvable collagen plugs; Semi-permanent: silicone or non-dissolvable plugs; Permanent: surgical occlusion (cautery, punctoplasty).

PurposeUsed to retain tears for patients with severe dry eyes, often after conservative therapy fails.

inv-67: Tarsorrhaphy definition — surgical partial eyelid closure.

DefinitionTarsorrhaphy: surgical partial closure of the eyelids to protect the ocular surface.

IndicationUsed for exposure keratopathy or severe dry eye refractory to other therapies.

PurposeReduces corneal exposure to promote healing and prevent further surface damage.

inv-68: Autologous serum tears — definition and intended use for severe dry eye.

DefinitionAutologous serum tears: eye drops prepared from the patient’s own serum, sometimes mixed with other substances.

Intended useProposed for severe dry eye (e.g., Sjogren syndrome, GVHD) with limited and variable RCT evidence.

Evidence noteCochrane review identified small RCTs with heterogeneous results; used as a treatment option in severe cases.

inv-69: InflammaDry (MMP-9 test) — point-of-care immunoassay detecting MMP-9 >= ~40 ng/mL.

DefinitionInflammaDry: a point-of-care immunoassay detecting tear MMP-9 as a marker of ocular surface inflammation.

Positive threshold>= 40 ng/mL MMP-9 considered positive on InflammaDry.

Clinical roleCan aid diagnosis and assess change in disease state but does not differentiate DED from other inflammatory ocular surface diseases.

inv-70: Dry eye disease (DED) — clinical definition of DED as multifactorial disease of tears and ocular surface.

DefinitionDry eye disease (DED): a multi-factorial disease of the tears and ocular surface causing tear film instability and potential ocular surface damage.

Clinical featuresSymptoms include discomfort and visual disturbance; severity ranges from mild to severe with risk of corneal damage in severe cases.

Epidemiology noteGlobal prevalence ranges widely (6–34%); more common in older adults and women.

inv-71: Thermal pulsation treatment — device-based therapy (e.g., LipiFlow) applying heat and pressure to meibomian glands.

DefinitionThermal pulsation treatment: device-based therapy applying heat and pressure to meibomian glands (e.g., LipiFlow).

MechanismAims to improve meibomian gland function and tear film metrics in meibomian gland dysfunction (MGD)/DED.

Clinical findingsStudies report improvements in TBUT, MMP-9 positivity, osmolarity and symptoms in some cohorts.

inv-72: Tear MUC5AC — goblet cell–specific mucin measured in tear fluid; association with Sjogren dry eye.

DefinitionTear MUC5AC: goblet cell–specific mucin measured in tear fluid by ELISA.

AssociationLower MUC5AC levels are associated with Sjogren-related dry eye and increased conjunctival staining.

Potential useMay help differentiate Sjogren versus non-Sjogren dry eye when combined with cytokine measures like IL-8.

inv-73: Tear lactoferrin — lacrimal gland–derived protein measured in tears; decreased with lacrimal dysfunction.

DefinitionTear lactoferrin: a lacrimal gland–derived protein measurable in tears; decreased in lacrimal dysfunction.

CorrelationLactoferrin concentrations correlate with Schirmer and TFBUT and inversely with symptom scores and dye staining.

Routine useAAO guidelines do not recommend routine measurement of tear lactoferrin in standard workup.

inv-74: MUC5AC — goblet cell–specific mucin measured in tears; reduced in Sjogren syndrome dry eye.

DefinitionMUC5AC: goblet cell–specific mucin measured in tears; reduced levels associated with Sjogren syndrome dry eye.

Clinical implicationReduced MUC5AC associated with increased conjunctival staining and may aid differential diagnosis.

MeasurementMeasured by ELISA in research settings; not yet a routine clinical test.

inv-75: Intense Pulsed Light (IPL) — definition and proposed mechanism for treating MGD-related dry eye.

DefinitionIntense Pulsed Light (IPL): non-laser high-intensity light delivering bursts that convert to heat for treating MGD-related dry eye.

Proposed mechanismMay modify meibomian gland function and improve tear film parameters when combined with gland expression.

Evidence noteRCT evidence is limited (few small trials); Cochrane review found scarce/low-certainty evidence.

inv-76: TOSCNFs + PRP — investigational topical formulation combining TEMPO-oxidized sacchachitin nanofibers and platelet-rich plasma.

DefinitionTOSCNFs + PRP: investigational topical formulation combining TEMPO-oxidized sacchachitin nanofibers with platelet-rich plasma.

Development stageEvaluated in preclinical and animal models; proposed for severe DES but investigational in humans.

Practical issuesStability of released growth factors in hydrogel vehicle is a challenge for clinical application.

inv-77: Dry eye disease (DED) — restated description as a common inflammatory ocular surface condition.

DefinitionDry eye disease (DED): common inflammatory condition of the ocular surface causing tear film instability and potential ocular surface damage.

Clinical spectrumRanges from mild symptoms to severe disease with risk of corneal damage and vision loss.

AssessmentRecommended to combine at least two objective tests (e.g., Schirmer, TFBUT, osmolarity) for evaluation.

Policy Summary

PayerAetna

PolicyDry Eyes

Policy CodePolicy 0457

Change TypeNone (no material changes)

Effective DateN/A

Last ReviewJul 11, 2023

Next Review DateN/A

Key ActionDocument diagnosis of severe dry eyes with objective evidence (e.g., Schirmer test, tear break-up time, or ocular surface staining) before submitting for punctal procedures.

SourceLink

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Dry Eyes

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Coverage Criteria and Policy Determinations

Evidence summaries (no coverage rules present)

Evidence summaries (no coverage rules present) — aggregated evidence summaries without explicit coverage nodes.

Coding — Covered and Not Covered Codes; Clinical Thresholds

CPT codes covered if selection criteria are metCPTCovered

68760	Closure of the lacrimal punctum; by thermocauterization, ligation, or laser surgery.
68761	Closure of the lacrimal punctum; by plug, each.
68801	Dilation of lacrimal punctum, with or without irrigation.
83861	Microfluidic analysis utilizing an integrated collection and analysis device, tear osmolarity.

HCPCS codes covered if selection criteria are metHCPCSCovered

A4262	Temporary, absorbable lacrimal duct implant, each.
A4263	Permanent, long-term, nondissolvable lacrimal duct implant, each.

CPT codes not covered for indications listedCPTNot Covered

0232T	Injection(s), platelet rich plasma, any site, including image guidance, harvesting and preparation when performed [combined with TEMPO-oxidized sacchachitin nanofibers (TOSCNFs)].
0330T	Tear film imaging, unilateral or bilateral, with interpretation and report.
83516	Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method.

HCPCS/J-codes not covered for indications listedmixedNot Covered

J0585	Botulinum toxin type A, per unit [Botox].
J9312	Injection, rituximab, 10 mg.
J1438	Injection, etanercept, 25 mg.

ICD-10 codes covered if selection criteria are metICD-10Covered

H04.121 - H04.129	Dry eye syndrome.
H04.561 - H04.569	Stenosis of lacrimal punctum.
H11.141 - H11.149	Conjunctival xerosis, unspecified.
H16.221 - H16.229	Keratoconjunctivitis sicca, not specified as Sjögren's.
M35.0 - M35.09	Sicca syndrome [Sjögren].