PterygiumMMCNCT06944132
CsA vs MMC for Preventing Pterygium Recurrence
A study testing Excision of the pterygium, Post-operative application of CsA and Intra-operative application of MMC in people with Pterygium and Pterygium of the Conjunctiva and Cornea, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pterygium, Pterygium of the Conjunctiva and Cornea
- What is being tested?
- Excision of the pterygium, Post-operative application of CsA and Intra-operative application of MMC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pterygium, Pterygium of the Conjunctiva and Cornea
- Being tested
- Excision of the pterygium, Post-operative application of CsA, Intra-operative application of MMC
- Keywords
- pterygium, Mitimycin C, Cyclosporin A
- Medical subject headings
- Pterygium, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excision of the pterygiumProcedure or surgery
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 CsADrug
Patients received topical cyclosporin A (0.05%) twice daily for three months postoperatively.
Intra-operative application of MMCDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (CsA Group) | Active comparator | Patients received topical cyclosporin A (0.05%) twice daily for three months postoperatively. Receives: 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 Receives: Procedure: Excision of the pterygium; Drug: Intra-operative application of MMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate of pterygium
the recurrence rate of pterygium, defined as fibrovascular regrowth over the cornea of at least 1 mm
Measured: 6 months after surgery
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Apr 2024
- Primary completion30 Sep 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
- Investigators
- Ehab Saad, Lecturer, Principal investigator, Benha University, Ebsar Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944132
- Sponsor's protocol ID
- CsA vs MMC for pterygium
- Other IDs
- Benha University
- Acronym
- MMC
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Use of Topical Cyclosporin A Versus Mitomycin C to Prevent Pterygium Recurrence
- ClinicalTrials.gov ID
- NCT06944132
- Acronym / sponsor ID
- MMC / CsA vs MMC for pterygium
- Conditions
- Pterygium, Pterygium of the Conjunctiva and Cornea
- Keywords
- pterygium, Mitimycin C, Cyclosporin A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (CsA Group) | Active comparator | Procedure: Excision of the pterygium, Drug: Post-operative application of CsAPatients received topical cyclosporin A (0.05%) twice daily for three months postoperatively. |
| Group B (MMC Group) | Active comparator | Procedure: Excision of the pterygium, Drug: Intra-operative application of MMCPatients received a single intraoperative application of mitomycin C (0.02%) for two minutes during surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excision of the pterygiumThe 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. | Procedure or surgery | Group A (CsA Group), Group B (MMC Group) |
| Post-operative application of CsAPatients received topical cyclosporin A (0.05%) twice daily for three months postoperatively. | Drug | Group A (CsA Group) |
| Intra-operative application of MMC0.02% 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 | Group B (MMC Group) |
Primary outcome
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
3 secondary outcomes
Change in parameter OSDI (ocular surface disease index) from 0 to 100 points.
Time frame: 6 months after surgery
Change in clinical parameter Schirmer test (from 0 to 15 mm)
Time frame: 6 months after surgery
Change in clinical parameter (TBUT)
Time frame: 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ehab Saad, Lecturer principal investigator
Benha University, Ebsar Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excision of the pterygium, Post-operative application of CsA and Intra-operative application of MMC in people with Pterygium and Pterygium of the Conjunctiva and Cornea, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate of pterygium (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.