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Study on a new eye ointment called Tacrolimus to help patients recover better after cornea replacement surgery for fungal eye Infection

Topical Tacrolimus as Adjunctive Therapy in Mycotic Corneal Ulcers Post Therapeutic Penetrating Keratoplasty - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112284
Enrollment
218
Registered
2026-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: H160- Corneal ulcer

Interventions

Intervention1: Topical Tacrolimus ointment 0.1% 4 times a day until 1 month post therapeutic penetrating keratoplasty along with anti fungal eye drops natamycin 5% hourly for 2 days and 2 hourly until

Sponsors

Aravind Eye Hospital, Pondicherry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Presence of smear or culture positive fungal ulcer requiring therapeutic penetrating keratoplasty 2. Ulcers with no infiltrate within 1 mm from limbus 3.Able to follow up until 6 months

Exclusion criteria

Exclusion criteria: 1. Evidence of herpetic, acanthamoeba, bacterial or pythium infection 2. History of intraocular surgery within last three months 3. Evidence of scleral involvement/scleral abscess 4. TPK done for graft infections Repeat keratoplasty 5. Tectonic keratoplasties with no/poor visual prognosis 6. Posterior segment involvement like endophthalmitis/RD/CD

Design outcomes

Primary

MeasureTime frame
To analyse the graft success rate between the treatment and control arm. Graft success measured as a)Clarity of graft b)Anterior chamber formation enabling secondary optical keratoplasty procedure Timepoint: 6 months

Secondary

MeasureTime frame
To analyse the best spectacle corrected visual acuity (BSCVA) between the treatment and control arm Timepoint: 3 months;To analyse the rate of complications like secondary glaucoma or endophthalmitisTimepoint: 3 months;To analyse the rate of recurrent infection between the treatment and control armTimepoint: 1, 2 and 3 months;Optical transplant survivalTimepoint: 1 year

Countries

India

Contacts

Public ContactDr Josephine Christy S

Aravind Eye Hospital, Pondicherry

josephine@aravind.org04132619100

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026