Evaluation of Conjunctival Autografting With MMC Application Versus Ologen Implantation of Recurrent Pterygium

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Evaluation of Conjunctival Autografting Augmented With Mitomycin-C Application Versus Ologen Implantation in Surgical Treatment of Recurrent Pterygium

Conditions
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Recurrent Pterygium of Eye

Intervention / Treatment
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* Procedure: conjunctival autografting augmented with topical application of Mitomycin C
* Procedure: conjunctival autografting augmented with Ologen implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: recurrent nasal pterygium after one surgical session for removal of the primary one Exclusion Criteria: primary nasal pterygium, recurrent pterygium with more than one session for surgical removal
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conjunctival autografting with MMC<br>Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL). | Procedure: conjunctival autografting augmented with topical application of Mitomycin C<br>* Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).<br>Procedure: conjunctival autografting augmented with Ologen implantation<br>* Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.<br>|
| Active Comparator: conjunctival autografting augmented with Ologen implantation<br>Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation. | Procedure: conjunctival autografting augmented with topical application of Mitomycin C<br>* Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).<br>Procedure: conjunctival autografting augmented with Ologen implantation<br>* Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 32 eyes with Topical application of Mitomycin C in concentration of (0.2 mg/mL). | 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). | through study completion, an average of 1 year. | 
| 31 eyes with ologen implantation(6 mm in diameter and 2 mm thick.) was used for each patient. | In group B; Ologen was applied under the graft tissue once it is secured in place (half the vial is used for every patient) | through study completion, an average of 1 year. |