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Comparative Efficacy of Lumecca IPL, Forma Eye, Combined Lumecca IPL Plus Forma Eye, and Lubricant Control in the Treatment of Meibomian Gland Dysfunction (MGD)-Related Dry Eye Disease

Comparative efficacy of Lumecca IPL, Forma Eye, Combined Lumecca IPL plus Forma Eye, and Lubricant Control for the Treatment of Meibomian Gland Dysfunction (MGD)-Related Dry Eye - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100258
Enrollment
104
Registered
2026-01-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

None listed

Interventions

Intervention1: Combined IPL and Forma Eye: Combination of Intense Pulse Light Therapy and Radio frequency Intervention2: Forma Eye: Forma Eye (or Forma-I) is a non-invasive radiofrequency (RF) therapy

Sponsors

ProSight Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: diagnosed MGD-related DED (based on TFOS DEWS II criteria: OSDI score, NIBUT, and evidence of gland dysfunction on meibography) Fitzpatrick skin types I-IV (for IPL safety, Groups A and C).

Exclusion criteria

Exclusion criteria: Active ocular infection, inflammation (e.g., severe blepharitis not related to MGD), or ocular surgery within 3 months. History of ocular herpes simplex or zoster. Use of topical antiglaucoma medications Use of systemic medications affecting tear production (e.g., isotretinoin, antihistamines) unless stable for more than 3 months. Pregnancy, lactation, or planning pregnancy. Photosensitivity disorders, epilepsy, or use of photosensitizing drugs (for IPL, Groups A and C). Pacemakers, metal implants near the eye, or coagulopathies (for RF, Groups B and C). Severe systemic diseases (e.g., uncontrolled diabetes, autoimmune disorders affecting the eyes).

Design outcomes

Primary

MeasureTime frame
- Visual Acuity (Uncorrected and Best Corrected) - Non-Invasive Break-Up Time (NIBUT) Timepoint: - Baseline and 3 months

Secondary

MeasureTime frame
-Meibography to evaluate meibomian gland morphology & atrophy -Ocular Surface Disease Index (OSDI) Scoring: Patient-reported symptom severity (0-100 scale). Validated 12-item questionnaire; higher scores indicate worse symptoms. -Schirmers 1 test -Schirmers 2 test Timepoint: Baseline & 3 months

Countries

India

Contacts

Public ContactDr Sheetal Brar

ProSight Eye Hospital

sheetalbrar1@gmail.com09591002092

Outcome results

None listed

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