N/A
N=96
Recurrent Pterygium Surgery Using Mitomycin C With Limbal Conjunctival or Amniotic Membrane
Recurrent Pterygium
Bottom Line
View on ClinicalTrials.gov: NCT01319721 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Recurrence — 46; 34; 0; 3 eyes — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MMC (Procedure); LCAG (Procedure); AMG (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shiyou Zhou
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence |
46; 34; 0; 3; 0; 2 | <0.05 sig |
| SECONDARY Complications |
9; 8 | <0.05 sig |
| SECONDARY Healing Time of Corneal Epithelial Defect |
2.78; 3.25 | 0.05 |
| SECONDARY Eye Movement Amplitude (EMA) |
6.67; 6.79; 8.35; 7.85; 1.67; 1.06 | <0.05 sig |
| SECONDARY Postoperative Conjunctival Inflammation |
21; 14; 17; 14; 9; 13 | <0.05 sig |
Summary
To compare the outcomes of limbal conjunctival autograft (LCAG) versus amniotic membrane graft (AMG) when combined with intraoperative 0.02% mitomycin C (MMC) after pterygium removal in patients with recurrent pterygium.
Eligibility Criteria
Inclusion Criteria
- The patients had one or two eye(s) with unilateral recurrent pterygium.
- Recurrent pterygium：be defined as of fibrovascular tissue onto the cornea for any distance in the position of a previous pterygium.
- Willingness to participate in research project and to attend research time.
Exclusion Criteria
- Poor general health.
- Pregnant or lactating women.
- Patients with collagen vascular diseases or other autoimmune diseases.
- Patients with any evidence of stem cell deficiency.
- Patients with glaucoma who might require future filtering surgery.
- Patients with ocular infection.
- Patients with an allergy to mitomycin C, tobramycin or dexamethasone.
Data sourced from ClinicalTrials.gov (NCT01319721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.