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

This study is currently recruiting participants.
Verified February 2013 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: February 28, 2013
Last verified: February 2013
History of Changes
  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: MMC and LCAG
Procedure: MMC and AMG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

Drug Information available for: Mitomycin
U.S. FDA Resources

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

Primary Outcome Measures:
  • Recurrence Rate and Complications [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Eye Movement Amplitude [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
  • Corneal Epithelial Wound Healing [ Time Frame: Four Weeks ] [ Designated as safety issue: Yes ]
  • Subjective Symptom [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 96
Study Start Date: December 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MMC and 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: MMC and LCAG
After excision of recurrent pterygium, low-dose mitomycin C (0.02%) for 3 minutes will be applied topically to the defect area and a limbal conjunctival autograft will be applied thereafter.
Other Names:
  • intraoperative mitomycin C and limbal conjunctival autograft
  • Mitomycin C and limbal conjunctival transplantation
  • mitomycin C
  • limbal conjunctiva
Active Comparator: MMC and 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: MMC and AMG
After excision of recurrent pterygium, low-dose mitomycin C (0.02%) for 3 minutes will be applied topically to the defect area and an amniotic membrane graft will be applied thereafter.
Other Names:
  • intraoperative mitomycin C and amniotic membrane graft
  • Mitomycin C and amniotic membrane transplantation
  • mitomycin C
  • amniotic membrane graft
  • amniotic membrane transplantation

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.

  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
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     gdeyeb@yahoo.com.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: February 28, 2013
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
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on May 19, 2013