CsA vs MMC for Preventing Pterygium Recurrence (MMC)

Adjunctive Use of Topical Cyclosporin A Versus Mitomycin C to Prevent 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.

Study Overview

• Status: Completed
• Conditions: Pterygium; Pterygium of the Conjunctiva and Cornea
• Intervention / Treatment: Procedure: Excision of the pterygium; Drug: Post-operative application of CsA; Drug: Intra-operative application of MMC

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 4450113
    • Ebsar Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (CsA Group); Patients received topical cyclosporin A (0.05%) twice daily for three months postoperatively.	Procedure: Excision of the pterygium; 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.; Drug: Post-operative application of CsA; Patients received topical cyclosporin A (0.05%) twice daily for three months postoperatively.
Active Comparator: Group B (MMC Group); Patients received a single intraoperative application of mitomycin C (0.02%) for two minutes during surgery	Procedure: Excision of the pterygium; 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.; Drug: Intra-operative application of MMC; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence rate of pterygium	the recurrence rate of pterygium, defined as fibrovascular regrowth over the cornea of at least 1 mm	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in parameter OSDI (ocular surface disease index) from 0 to 100 points.	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.	6 months after surgery
Change in clinical parameter Schirmer test (from 0 to 15 mm)	The Schirmer test score is determined by measuring the length of the strips' moistened area against fluid movement	6 months after surgery
Change in clinical parameter (TBUT)	Change in clinical parameter Tear breakup time (TBUT) from less than 5 to more than 10 seconds	6 months after surgery

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Ehab Saad, Lecturer, Benha University, Ebsar Eye Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): October 15, 2024

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: pterygium; Cyclosporin A; Mitimycin C
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Eye Diseases; Conjunctival Diseases; Recurrence; Pterygium
• Other Study ID Numbers: CsA vs MMC for pterygium; Benha University (Other Identifier: Al-Azhar University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No