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A study comparing Oral Mycofenolate mofetil and topical Tacrolimus to prevent graft rejection after high risk corneal transplant surgery.

Systemic Mycophenolate Mofetil vs Topical Tacrolimus for prevention of graft rejection after high risk penterating keratoplasty

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089826
Enrollment
108
Registered
2025-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: H179- Unspecified corneal scar and opacity

Interventions

Intervention1: Systemic Mycophenolate Mofetil: 1g twice daily for 1 month followed by 500mg twice daily 11 months Control Intervention1: Topical Tacrolimus 0.1% eye ointment: 4 times daily for 1 month

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing penetrating keratoplasty with either more than equal to 2 quadrants of deep stromal neovascularization (more than 2 mm) , or Repeat corneal grafts

Exclusion criteria

Exclusion criteria: Patients with uncontrolled glaucoma, active microbial keratitis or limbal stem cell deficiency, pregnant and lactating females, patients with a history of malignancy, patients having uncontrolled diabetes or hypertension, patients with systemic infections , patients with gastrointestinal diseases or abnormal hematologic, hepatic or renal function.

Design outcomes

Primary

MeasureTime frame
Endothelial graft rejectionTimepoint: Between 2 weeks of keratoplasty till the last follow up visit (atleast 6 months, 12 months desirable)

Secondary

MeasureTime frame
Graft survivalTimepoint: 6months , 12 months;Proportion of reversible graft rejection episodes.Timepoint: ;Rate of systemic and ocular adverse eventsTimepoint: ;Best corrected visual acuityTimepoint: Last follow up;BAASIS questionnaireTimepoint: 21 days, 3 most, 6 months, 12 months

Countries

India

Contacts

Public ContactAashima Sachdeva

Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS New Delhi

aashimasachdeva012@gmail.com9355123052

Outcome results

None listed

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