Recurrent Pterygium of Eye Clinical Trial
Official title:
Evaluation of Conjunctival Autografting Augmented With Mitomycin-C Application Versus Ologen Implantation in Surgical Treatment of Recurrent Pterygium
Ologen implantation with conjunctival autografting shows promising results in surgical management of recurrent pterygium comparable to MMC application with conjunctival autografting with mild non vision threatening postoperative complications.
Patients were randomly enrolled into two groups. Group A included 32 eyes of 32 patients who
underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2
mg/mL). Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with
Ologen implantation.
All patients had a recurrent nasal pterygium after one surgical session for removal of the
primary one. Any patient with primary nasal pterygium, or patients with recurrent pterygium
who had more than one session for surgical removal were excluded. As well, patients with
cicatrizing conjunctival disease or previous conjunctival surgery were excluded from the
study.
A comprehensive ophthalmic examination, including best-corrected visual acuity testing,
slit-lamp examination, Goldmann applanation tonometry, fundus examination, and examination of
ocular motility, was carried out for all patients. According to their corneal extent,
pterygia were classified into 3 grades:
Grade 1: Fibrovascular proliferations extend up to one quarter of the corneal diameter.
Grade 2: Fibrovascular proliferations extend up to the center of the cornea. Grade 3:
Fibrovascular proliferations extend beyond the visual axis.
Consents were taken from all patients and research was approved by the institutional review
board. All measures were in accordance with the tenets of the Declaration of Helsinki.
As for group A, 0.2 mg/mL MMC was prepared by reconstituting 2 mg vial of Mitomycin with 10
mL sterile water for injection. When using Mitomycin 10 mg vial, the same concentration was
achieved by reconstituting the 10 mg vial 10 mL sterile water for injection. Then 1 ml of the
prepared solution was diluted with 4 ml of saline to achieve 0.2 mg/mL (0.02% solution). This
solution is stable for 2 weeks under refrigeration, and 24 hours at room temperature (59° to
86°F).
As for group B, 1×2 or 2×2 square millimeter porous collagen matrix was used for each patient
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04075227 -
Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium
|
Phase 4 |