Recurrent Pterygium Surgery Using Mitomycin C With Limbal Conjunctival or Amniotic Membrane

Recurrent Pterygium Clinical Trial

Official title:

Limbal Conjunctival Autograft Versus Amniotic Membrane Graft When Combined With Mitomycin C for Recurrent Pterygium: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01319721
• Other study ID #: 20101215
• Status: Completed
• Phase: N/A
• First received: March 21, 2011
• Last updated: March 5, 2015
• Start date: December 2010
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Excision alone for treating recurrent pterygium was reported to be at risk of high recurrence again. As one of adjunctive methods, intraoperative application of a single dose of mitomycin C (MMC) seems to be the most commonly used method for preventing recurrence of pterygium. Additionally, closure of conjunctival defect after excision of pterygium by limbal conjunctival autograft or amniotic membrane have also become popular in recent years. There are a few reports in which MMC combined either limbal conjunctival autograft (LCAG) or amniotic membrane graft (AMG) for the treatment of recurrent pterygium. To assess the effectiveness and safety of these two combined approaches, the investigator plans to work on a randomized comparative and prospective trial of recurrent pterygium extensive excision with intraoperative 0.02% MMC application comparing LCAG to AMG.The patients enrolled in this study will be followed for at least 12 months after the surgery. Recurrence was defined as fibrovascular tissue crossing the limbus on to the clear cornea in the area of previous pterygium excision.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterygium
• Recurrent Pterygium

Intervention

Procedure:
• MMC
Intraoperative 0.2mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically after extensive excision of recurrent pterygium.
• LCAG
Limbal conjunctival autograft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.
• AMG
Amniotic membrane graft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.

Locations

Country	Name	City	State
China	State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shiyou Zhou

Country where clinical trial is conducted

China, 

Outcome

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