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Feasibility of Novel Grafts for Emergency Corneal replacement

Use of Gamma-Irradiated, Pre-cut Corneal Lenticules for Tectonic Keratoplasty in Patients with perforated corneal disease â?? A pilot study - GATE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/028858
Enrollment
20
Registered
2020-11-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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 Health Condition 2: H168- Other keratitis

Interventions

Intervention1: Tectonic Keratoplasty: Emergency Tectonic Keratoplasty for patients with perforated corneal disease due to infection or trauma It is a 45 minutes surgery which will be done within 48 ho

Sponsors

Aravind Eye Hospital Pondicherry
Lead Sponsor
CorneaGen
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Perforated corneal ulcer of size â?? more than 6 mm but with at least 2 mm clear margin from limbus

Exclusion criteria

Exclusion criteria: Patients with potential good visual outcome with normal corneal transplants â?? Ulcer size less than 6mm Mono-ocular patient with other eye vision less than 6/60 Co-existing endophthalmitis or retinal detachment requiring retinal procedures

Design outcomes

Primary

MeasureTime frame
Anatomical success - the restoration of tectonic integrity of globe Therapeutic success - defined as complete eradication of primary infection after keratoplasty with appropriate adjunctive medical therapy Timepoint: 1 month and 6 months

Secondary

MeasureTime frame
1. Functional success - preservation of visual function with post op BCVA ranging from perception of light (PL), accurate projection of rays (PR) to 20/40 Complications Re-Surgeries like AC wash or AC reformation Adjunctive surgical procedures for graft epithelial healing Recurrent infection Recurrent perforation or graft melt Graft failure Glaucoma Timepoint: At 1 month and 6 months

Countries

India

Contacts

Public ContactDr Josephine Christy

Aravind Eye Hospital

josephine@aravind.org9994549584

Outcome results

None listed

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