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Completed

NCT Number: NCT06944132

CsA vs MMC for Preventing Pterygium Recurrence

aimed to compare the efficacy and safety of topical cyclosporin A (CsA) versus mitomycin C (MMC) as adjunctive therapies in preventing pterygium recurrence after surgical excision.

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Key information

Conditions

Pterygium Conjunctival Diseases Corneal Diseases Eye Diseases Pterygium of the Conjunctiva and Cornea

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ebsar Eye Center

Cairo, Egypt, 4450113

About this study

A total of 40 eyes from 40 patients undergoing pterygium surgery were randomized into two groups: Group A received topical cyclosporin A, while Group B was treated with topical mitomycin C. Ocular surface inflammation scores, recurrence rates, patient-reported symptoms, and adverse effects were assessed at baseline and during follow-up at 6 months postoperatively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 years or older.
  • Diagnosed with primary pterygium extending at least 1 mm onto the cornea.
  • No prior history of pterygium surgery in the affected eye.

Exclusion criteria

  • History of ocular surface diseases such as dry eye or Sjögren's syndrome.
  • Active ocular infection.
  • Known hypersensitivity to CsA or MMC.
  • Systemic conditions requiring immunosuppressive therapy.

Treatment and study plan

Excision of the pterygium

Procedure

The surgical procedure involved excision of the pterygium, including the fibrovascular head and associated conjunctival tissue, followed by bare sclera closure using an autologous conjunctival graft harvested from the superior bulbar conjunctiva. The graft was secured in place using either fibrin glue or 8-0 absorbable sutures. In Group B, 0.02% mitomycin C (MMC) was applied to the bare sclera for two minutes using a soaked sponge, followed by thorough irrigation with balanced salt solution.

Post-operative application of CsA

Drug

Patients received topical cyclosporin A (0.05%) twice daily for three months postoperatively.

Intra-operative application of MMC

Drug

0.02% mitomycin C (MMC) was applied to the bare sclera for two minutes using a soaked sponge, followed by thorough irrigation with balanced salt solution.

Primary outcomes

  1. recurrence rate of pterygium

    Time frame: 6 months after surgery

    the recurrence rate of pterygium, defined as fibrovascular regrowth over the cornea of at least 1 mm

Secondary outcomes

  1. Change in parameter OSDI (ocular surface disease index) from 0 to 100 points.

    Time frame: 6 months after surgery

    OSDI (from 0 to 100 points) where patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time" a final score is calculated which ranges from 0 to 100 with scores and based on their OSDI scores, patients can be categorized as having a normal ocular surface (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) ocular surface disease.

  2. Change in clinical parameter Schirmer test (from 0 to 15 mm)

    Time frame: 6 months after surgery

    The Schirmer test score is determined by measuring the length of the strips' moistened area against fluid movement

  3. Change in clinical parameter (TBUT)

    Time frame: 6 months after surgery

    Change in clinical parameter Tear breakup time (TBUT) from less than 5 to more than 10 seconds

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Adjunctive Use of Topical Cyclosporin A Versus Mitomycin C to Prevent Pterygium Recurrence

Acronym: MMC

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 25, 2025
Registry last updated
Apr 25, 2025

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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