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Completed

NCT Number: NCT04419038

Evaluation of Conjunctival Autografting With MMC Application Versus Ologen Implantation 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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conjunctival autografting augmented with topical application of Mitomycin C

Procedure

Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).

conjunctival autografting augmented with Ologen implantation

Procedure

Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.

Primary outcomes

  1. 32 eyes with Topical application of Mitomycin C in concentration of (0.2 mg/mL).

    Time frame: "through study completion, an average of 1 year".

    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).

  2. 31 eyes with ologen implantation(6 mm in diameter and 2 mm thick.) was used for each patient.

    Time frame: "through study completion, an average of 1 year".

    In group B; Ologen was applied under the graft tissue once it is secured in place (half the vial is used for every patient)

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 5, 2020
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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