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

Phase 4

Recruitment & Eligibility

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

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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
n-corrected visual acuity (UCVA) and best-corrected visual <br/ ><br>acuity (BCVA) before and after the procedures. <br/ ><br>ï?· Adverse events, including failure of closure of perforation, <br/ ><br>dislocation of AMG, and Infection, at final follow-up.Timepoint: weekly