Recurrent Pterygium Clinical Trial
Official title:
Limbal Conjunctival Autograft Versus Amniotic Membrane Graft When Combined With Mitomycin C for Recurrent Pterygium: A Randomized Trial
Verified date | March 2015 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 96 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Shiyou Zhou |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence | Recurrence was defined as the presence of fibrovascular tissue in the surgical area and invasion onto the cornea. The appearance of the surgical bed in successful cases was graded as follows: grade A was defined as the operated eye being indistinguishable from a normal eye, grade B was defined as the presence of fine episcleral vessels without fibrous tissue in the surgical area extending up to the limbus but not beyond, and grade C was defined as the presence of fibrovascular tissue in the surgical area but without invasion onto the cornea. | One Year | No |
Secondary | Complications | One year | Yes | |
Secondary | Healing Time of Corneal Epithelial Defect | Four Weeks | No | |
Secondary | Eye Movement Amplitude (EMA) | One Year | No | |
Secondary | Postoperative Conjunctival Inflammation | The presence of conjunctival inflammation around the surgical site was assessed at 4 weeks post-operatively and graded as 0 (none), i (mild), ii (moderate), and iii (severe). | One month | No |
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