CsA vs MMC for Preventing Pterygium Recurrence

NCT06944132 | Completed

• 2 other identifiers: CsA vs MMC for pterygiumBenha University
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pterygium; Pterygium of the Conjunctiva and Cornea

Keywords

pterygium; Mitimycin C; Cyclosporin A

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  6 months after surgery

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

  6 months after surgery

• Change in clinical parameter (TBUT)

  6 months after surgery

Study Arms (2)

Group A (CsA Group)

ACTIVE COMPARATOR

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

Procedure: Excision of the pterygium; Drug: Post-operative application of CsA

Group B (MMC Group)

ACTIVE COMPARATOR

Patients received a single intraoperative application of mitomycin C (0.02%) for two minutes during surgery

Procedure: Excision of the pterygium; Drug: Intra-operative application of MMC

Interventions

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.

Group A (CsA Group); Group B (MMC Group)

Post-operative application of CsA DRUG

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

Group A (CsA Group)

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.

Group B (MMC Group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Ebsar Eye Center

Cairo, Egypt, 4450113, Egypt

Location

MeSH Terms

Conditions

Pterygium; Corneal Diseases

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Study Officials

• Ehab Saad, Lecturer

  Benha University, Ebsar Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 25, 2025
• Study Start: April 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 15, 2024
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

EG (1)