Trials / Unknown
UnknownNCT04463901
Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium Using Mitomycin C
Intraoperative Mitomycin C Combined With Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium: a Randomized Clinical Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- Sponsor
- Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this randomized clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC) combined with limbal conjunctival autograft(LCAG) or conjunctival autograft(CAG) for recurrent pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence
Detailed description
Intraoperative mitomycin C after pterygium excision is widely used to prevent recurrce of recurrent pterygium. Conjunctival autograft with or without limbal tissue used to cover the bare sclera will efficiently reduce postoperative longstanding epithelial defect. Patients with recurrent pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C with conjunctival autograft or limbal conjunctival autograft .The patients will be followed at least 12 months. Corneal recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag in the area of previous pterygium excision.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Pterygium excision | Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue. |
| PROCEDURE | Intraoperative mitomycin C | Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision. |
| PROCEDURE | Conjunctival autograft | A conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision. |
| PROCEDURE | Limbal conjunctival autograft | A limbal conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision. |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2021-07-01
- Completion
- 2021-07-01
- First posted
- 2020-07-09
- Last updated
- 2020-07-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04463901. Inclusion in this directory is not an endorsement.