NCT04463901

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

5.4 years

First QC Date

July 4, 2020

Last Update Submit

July 4, 2020

Conditions

Recurrent Pterygium

Keywords

recurrent pterygiumpterygiumlimbal conjunctival autograftconjunctival autograftmitomycin c

Outcome Measures

Primary Outcomes (1)

  • Recurrence of pterygium

    One year

Secondary Outcomes (4)

  • Visual acuity

    One year

  • Healing time of corneal epithelium

    Four weeks

  • Healing time of conjunctival epithelium

    Four weeks

  • Postoperative complications

    One year

Study Arms (2)

Group CAG

ACTIVE COMPARATOR

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 excisionProcedure: Intraoperative mitomycin CProcedure: Conjunctival autograft

Group LCAG

ACTIVE COMPARATOR

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 excisionProcedure: Intraoperative mitomycin CProcedure: Limbal conjunctival autograft

Interventions

Pterygium excisionPROCEDURE

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

Group CAGGroup LCAG
Intraoperative mitomycin CPROCEDURE

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

Also known as: MMC
Group CAGGroup LCAG
Conjunctival autograftPROCEDURE

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

Also known as: CAG
Group CAG
Limbal conjunctival autograftPROCEDURE

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

Also known as: LCAG
Group LCAG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Study Officials

  • Zhou Shiyou, M.D., Ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhou Shiyou, M.D., Ph.D.

CONTACT

86-02087331540zhoushiy@mail.sysu.edu.cn

Zhou Tao, M.D.

CONTACT

86-18126813938taochou_tony@foxmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

July 4, 2020

First Posted

July 9, 2020

Study Start

February 1, 2016

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

July 9, 2020

Record last verified: 2020-07

Locations

CN(1)