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Punctal Cautery in Dry Eye Syndrome

Randomized Controlled Study on the Efficacy of Punctal Cautery in severe Dry Eye disease - Nil

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067575
Enrollment
50
Registered
2024-05-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: H578- Other specified disorders of eye and adnexa

Interventions

Intervention1: Punctal cautery: Participants in this group will undergo punctal cautery of the puncta bilaterally. 1 month and 3 month follow up. Control Intervention1: Sham procedure: Participants in

Sponsors

L V Prasad Eye Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged 5–70 years 2. Have OSDI scores =33 or Oxford staining grade =2 3. Diagnosis of DED in both eyes supported by the criteria mentioned below a.A symptom severity score of =33 for OSDI b.An unanesthetized Schirmer Tear Test (STT) score of =1 mm and =5 mm per 5 minutes c.Evidence of ocular surface staining (total fluorescein staining score of at least 3) [0-15 scale]) 4. Have normal lid anatomy and diagnosed with severe dry eye (ATDDE) 5. DED refractory to medical management

Exclusion criteria

Exclusion criteria: 1.History of punctal occlusion or punctal dilation. 2.Active ocular infection or inflammation. 3.Use of punctal plugs within the past 3 months. 4.Pregnancy or lactation women. 5.Any systemic or ocular condition that may interfere with the study assessments or participant safety. 6.Punctal plug or contact lenses. 7.Ocular surgery within 6 months. Have no contraindication for blood donation 8.Positive HIV, hepatitis B or C, or syphilis.

Design outcomes

Primary

MeasureTime frame
Change in dry eye symptoms assessed using validated questionnaires such as the Ocular Surface Disease Index (OSDI) score.Timepoint: 1 month, 3 months

Secondary

MeasureTime frame
Visual Acuity, Adverse events related to interventionTimepoint: 1 month and 3 months

Countries

India

Contacts

Public ContactDrSwati Singh

L V Prasad Eye Institute

swatisingh@lvpei.org7036981646

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026