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A clinical trial to study the effect of combining platelet rich plasma and amniotic membrane graft for treatment of perforated corneal ulcer

Combined Platelet Rich Plasma and Amniotic Membrane Graft Versus Amniotic Membrane Graft Alone for Treatment of infectious Perforated Central Corneal Ulcer.

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051934
Enrollment
36
Registered
2023-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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: eye platelet rich plasma (E-PRP) and amniotic membrane graft (AMG) versus amniotic membrane graft (AMG) alone for the treatment of perforated corneal ulcer: two groups will be different

Sponsors

Faculty of Medicine zagzaig university hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients aged above 18 years old. 2. Perforated corneal ulcer following infectious keratitis either bacterial, fungal, viral or acanthamoeba keratitis as evidenced by positive Seidel testing. 3. Corneal perforation 2-4 mm size.

Exclusion criteria

Exclusion criteria: 1. Evidence of intraocular infection by B-scan ultrasound. 2. Perforated corneal ulcer or impending perforation after noninfectious keratitis either traumatic, immune or chronic allergy. 3. Perforation more than 4 mm size or less than 2 mm size. 4. Patients with NO PL visual acuity. 5. Iris or lens tissue prolapse. 6. Contraindications for Platelet Rich Plasma e.g. (platelet dysfunction syndrome, critical thrombocytopenia, hemodynamic instability and septicemia). 7. Contraindications for AMG e.g. (severe dry eye, lagophthalmos and severe necrosis caused by ischemia).

Design outcomes

Primary

MeasureTime frame
Sealing of perforation both clinically using slit lamp examination (SLE), negative Seidel testing and by anterior segment OCT (ASOCT) after 4 weeks of surgery. ï?· Anterior chamber (AC) formation and maintenance clinically. ï?· The stability of amniotic membrane by clinical examination and ASOCT. ï?· Presence and resolution of infectious keratitis. ï?· Digital assessment of intraocular pressure (IOP).Timepoint: at baseline then every week for 1 month—

Secondary

MeasureTime frame
Un-corrected visual acuity (UCVA) and best-corrected visual acuity (BCVA) before and after the procedures. ï?· Adverse events, including failure of closure of perforation, dislocation of AMG, and Infection, at final follow-up.Timepoint: weekly—

Countries

Egypt

Contacts

Public ContactMahmoud yaseen saber

zagzaig university hospitals

ashborai@yahoo.com00201065338080

Outcome results

None listed

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