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Completed

NCT Number: NCT01319721

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MMC

Procedure

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

Other names: mitomycin C

LCAG

Procedure

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

Other names: limbal conjunctiva, limbal conjunctival autograft, limbal conjunctival autograft transplantation

AMG

Procedure

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

Other names: amniotic membrane graft, amniotic membrane transplantation, amniotic membrane graft transplantation

Primary outcomes

  1. Recurrence

    Time frame: One Year

    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.

Secondary outcomes

  1. Complications

    Time frame: One year

  2. Healing Time of Corneal Epithelial Defect

    Time frame: Four Weeks

  3. Eye Movement Amplitude (EMA)

    Time frame: One Year

  4. Postoperative Conjunctival Inflammation

    Time frame: One month

    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).

Sponsors and collaborators

Lead sponsor

Shiyou Zhou

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Mar 22, 2011
Registry last updated
Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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