CsA vs MMC for Preventing Pterygium Recurrence

Not Applicable

Completed

• Conditions: Pterygium; Pterygium of the Conjunctiva and Cornea
• Interventions: Procedure: Excision of the pterygium; Drug: Post-operative application of CsA; Drug: Intra-operative application of MMC

• Registration Number: NCT06944132
• Lead Sponsor: Benha University

Brief Summary

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.

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 Timeline

• Study Start: 2024-04-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-10-15
• Status Verified: 2025-04
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-17
• Last Update Submitted: 2025-04-17
• Study First Posted: 2025-04-25
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (CsA Group)	Excision of the pterygium	Patients received topical cyclosporin A (0.05%) twice daily for three months postoperatively.
Group A (CsA Group)	Post-operative application of CsA	Patients received topical cyclosporin A (0.05%) twice daily for three months postoperatively.
Group B (MMC Group)	Excision of the pterygium	Patients received a single intraoperative application of mitomycin C (0.02%) for two minutes during surgery
Group B (MMC Group)	Intra-operative application of MMC	Patients received a single intraoperative application of mitomycin C (0.02%) for two minutes during surgery

Primary Outcome Measures

Name	Time	Method
recurrence rate of pterygium	6 months after surgery	the recurrence rate of pterygium, defined as fibrovascular regrowth over the cornea of at least 1 mm

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ebsar Eye Center; 🇪🇬 Cairo, Egypt