Recurrent Pterygium Surgery With Mitomycin C Application Using Limbal Conjunctival Versus Amniotic Membrane

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Shiyou Zhou, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01319721
First received: March 21, 2011
Last updated: June 15, 2014
Last verified: June 2014
  Purpose

The purpose of this trial is to compare two techniques for the treatment of recurrent pterygium: intraoperative mitomycin C plus limbal conjunctival autograft transplantation versus intraoperative mitomycin C plus amniotic membrane graft transplantation.


Condition Intervention
Recurrent Pterygium
Procedure: LCAG
Procedure: AMG
Procedure: MMC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recurrent Pterygium Surgery With Mitomycin C Application Using Limbal Conjunctival Autograft Versus Amniotic Membrane Graft: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Recurrence Rate [ Time Frame: One Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complication [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Healing Time of Corneal Epithelial Wound [ Time Frame: Four Weeks ] [ Designated as safety issue: No ]
  • Amplitude of Eye Movement [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Subjective Symptom [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: December 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MMC & LCAG
After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (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: LCAG
Limbal conjunctival autograft transplantation will be applied to closure of conjunctival defect after excision of recurrent pterygium.
Other Names:
  • limbal conjunctiva
  • limbal conjunctival autograft
  • limbal conjunctival autograft transplantation
Procedure: MMC
Intraoperative 0.2mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically after excision of recurrent pterygium.
Active Comparator: MMC & AMG
After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (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: AMG
Amniotic membrane graft transplantation will be applied to closure of conjunctival defect after excision of recurrent pterygium.
Other Names:
  • amniotic membrane graft
  • amniotic membrane transplantation
  • amniotic membrane graft transplantation
Procedure: MMC
Intraoperative 0.2mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically after excision of recurrent pterygium.

Detailed 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. Meanwhile, 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 complications of two combined approaches, the investigator plans to work on a randomized comparative and prospective trial of recurrent pterygium excision with intraoperative MMC application using LCAG versus 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent pterygium
  • Willingness to participate in research project and to attend research time

Exclusion Criteria:

  • Pregnant or breast-feeding women
  • Patients with significant ocular or lid pathology, such as infection, glaucoma and ocular hypertension
  • Patients with a history of other previous ocular surgeries or trauma
  • Patients with an allergy to mitomycin C, tobramycin or dexamethasone
  • Poor general health
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01319721

Contacts
Contact: Shiyou Zhou, M.D., Ph.D. 86-02087331540 zhoushiy@mail.sysu.edu.cn
Contact: Rongxin Chen, M.D. 86-02087333566 rongxinchan@foxmail.com

Locations
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Shiyou Zhou, MD, PHD    86-02087331550    zhoushiy@mail.sysu.edu.cn   
Contact: Rongxin Chen    86-02087333566    CRX_1986@163.com   
Principal Investigator: Rongxin Chen         
Sub-Investigator: Xiaofang Yin         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Director: Shiyou Zhou, MD, PHD Zhongshan Ophthalmic Center, Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Shiyou Zhou, M.D., Ph.D., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01319721     History of Changes
Other Study ID Numbers: 20101215
Study First Received: March 21, 2011
Last Updated: June 15, 2014
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
Amniotic membrane
Limbal conjunctival autograft
Limbal
Conjunctival
Mitomycin C
Recurrent pterygium
Pterygium

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014