Pterygium, Pterygium of the Conjunctiva and Cornea
Conditions
Keywords
pterygium, Mitimycin C, Cyclosporin A
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.
Interventions
PROCEDUREExcision 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.
DRUGPost-operative application of CsA
Patients received topical cyclosporin A (0.05%) twice daily for three months postoperatively.
DRUGIntra-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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed