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

NCT01319721 | Completed Results DMC

• 1 other identifier: 20101215
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Pterygium

Keywords

Amniotic membrane; Limbal conjunctival autograft; Limbal; Conjunctival; Mitomycin C; Recurrent pterygium; Pterygium

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Complications

  One year

• Healing Time of Corneal Epithelial Defect

  Four Weeks

• Eye Movement Amplitude (EMA)

  One Year

• Postoperative Conjunctival Inflammation

  One month

Study Arms (2)

Group LCAG

ACTIVE COMPARATOR

After extensive excision of recurrent pterygium, intraoperative 0.2 mg/ml MMC (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.

Procedure: MMC; Procedure: AMG

Group AMG

ACTIVE COMPARATOR

After excision of recurrent pterygium, intraoperative 0.2 mg/ml MMC (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.

Procedure: LCAG; Procedure: AMG

Interventions

MMC PROCEDURE

Intraoperative 0.2mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically after extensive excision of recurrent pterygium.

Also known as: mitomycin C

Group LCAG

LCAG PROCEDURE

Limbal conjunctival autograft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.

Also known as: limbal conjunctiva, limbal conjunctival autograft, limbal conjunctival autograft transplantation

Group AMG

AMG PROCEDURE

Amniotic membrane graft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.

Also known as: amniotic membrane graft, amniotic membrane transplantation, amniotic membrane graft transplantation

Group AMG; Group LCAG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shiyou Zhou: lead

Study Sites (1)

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Pterygium

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Shiyou Zhou
• Organization: State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University

zhoushiy@mail.sysu.edu.cn

+86-020-87331540

Study Officials

• Shiyou Zhou, MD, PHD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 22, 2011
• Study Start: December 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 19, 2015
• Results First Posted: March 19, 2015

Record last verified: 2015-03

Locations

CN (1)