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Status unknownNCT04463901Updated Jul 9, 2020

Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium Using Mitomycin C

An interventional study of Pterygium excision and Intraoperative mitomycin C in Recurrent Pterygium, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-09.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

The purpose of this randomized clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC) combined with limbal conjunctival autograft(LCAG) or conjunctival autograft(CAG) for recurrent pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence

Read the detailed description

Intraoperative mitomycin C after pterygium excision is widely used to prevent recurrce of recurrent pterygium. Conjunctival autograft with or without limbal tissue used to cover the bare sclera will efficiently reduce postoperative longstanding epithelial defect.

Patients with recurrent pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C with conjunctival autograft or limbal conjunctival autograft .The patients will be followed at least 12 months. Corneal recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag in the area of previous pterygium excision.

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Conditions studied

  • Recurrent Pterygium

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Keywords

  • recurrent pterygium
  • pterygium
  • limbal conjunctival autograft
  • conjunctival autograft
  • mitomycin c
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In context

Pterygium

109 studies on the registry are indexed under Pterygium; 9 are open to participants now.

This study's planned enrollment of 116 is above the median of 60 across 93 interventional studies indexed under Pterygium.

Browse Pterygium studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Recurrent pterygium
  • Willingness to participate in research project and to attend research time
  • At least 6 months after last pterygium surgery

Exclusion criteria

Exclusion Criteria:

  • Pregnant,breast-feeding women or poor general health
  • Patients with significant ocular or lid pathology, such as Sjogren's Syndrome ,infection, exposure keratitis,glaucoma and trauma
  • Patients with allergy to mitomycin C,tobramycin or local anesthetics
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
116 participants (estimated)

Study arms

  • Active comparator
    Group CAG

    After pterygium excision, intraoperative mitomycin c (0.02%) for 5 minutes will be applied topically onto the exposed surgical area and then conjunctival autograft without limbal tissue will be used to cover the bare sclera.

    Procedure: Pterygium excision · Procedure: Intraoperative mitomycin C · Procedure: Conjunctival autograft

  • Active comparator
    Group LCAG

    After pterygium excision, intraoperative mitomycin c (0.02%) for 5 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft will be used to cover the bare sclera.

    Procedure: Pterygium excision · Procedure: Intraoperative mitomycin C · Procedure: Limbal conjunctival autograft

Interventions

  • ProcedurePterygium excision

    Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue.

  • ProcedureIntraoperative mitomycin C

    Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.

    Also known as: MMC

  • ProcedureConjunctival autograft

    A conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.

    Also known as: CAG

  • ProcedureLimbal conjunctival autograft

    A limbal conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.

    Also known as: LCAG

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What researchers measure

Primary outcomes

  1. Recurrence of pterygium

    Time frame: One year

Secondary outcomes

  1. Visual acuity

    Time frame: One year

  2. Healing time of corneal epithelium

    Time frame: Four weeks

  3. Healing time of conjunctival epithelium

    Time frame: Four weeks

  4. Postoperative complications

    Time frame: One year

07

Study locations

1 of 1 sites recruiting
  • Zhongshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04463901
Responsible party
Shiyou Zhou (MD,PhD, Sun Yat-sen University) — Principal investigator
First posted
Jul 9, 2020
Start date
Feb 2016
Primary completion
Jul 2021 (estimated)
Completion
Jul 2021 (estimated)
Last update
Jul 9, 2020

Study contacts

Zhou Shiyou, M.D., Ph.D.
Contact
zhoushiy@mail.sysu.edu.cn
86-02087331540
Zhou Tao, M.D.
Contact
taochou_tony@foxmail.com
86-18126813938
Zhou Shiyou, M.D., Ph.D.
principal investigator · Zhongshan Ophthalmic Center, Sun Yat-sen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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