NCT03363282

Brief Summary

To study the efficacy and safety of amniotic membrane transplantation as an adjunctive therapy after surgical excision of primary pterygium and compare the clinical outcomes with conjunctival autograft

Trial Health

100
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Status
completed

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

September 17, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

November 30, 2017

Last Update Submit

March 7, 2018

Conditions

Pterygium of Conjunctiva and Cornea

Keywords

Crosslinking

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate

    Regrowth of pterygium

    one day

Study Arms (2)

Mini-SLET

EXPERIMENTAL

Simple Limbal Epithelial Transplantation

Procedure: Pterygium Excision

Limbal-Conjunctival Autograft

EXPERIMENTAL

Patients treated with limbal-conjunctival autograft

Procedure: Pterygium Excision

Interventions

Pterygium ExcisionPROCEDURE

Pterygium excision is the first step for repair

Also known as: Limbal-Conjunctival Autograft, Mini-SLET
Limbal-Conjunctival AutograftMini-SLET

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with primary nasal pterygium \> 2mm

You may not qualify if:

  • Pregnant
  • Previous ocular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Tseng SC. Concept and application of limbal stem cells. Eye (Lond). 1989;3 ( Pt 2):141-57. doi: 10.1038/eye.1989.22.

    PMID: 2695347RESULT

  • Tananuvat N, Martin T. The results of amniotic membrane transplantation for primary pterygium compared with conjunctival autograft. Cornea. 2004 Jul;23(5):458-63. doi: 10.1097/01.ico.0000116522.57227.97.

    PMID: 15220729RESULT

  • Kucukerdonmez C, Akova YA, Altinors DD. Comparison of conjunctival autograft with amniotic membrane transplantation for pterygium surgery: surgical and cosmetic outcome. Cornea. 2007 May;26(4):407-13. doi: 10.1097/ICO.0b013e318033b3d4.

    PMID: 17457187RESULT

  • Oliva-Bienzobas V, Nava-Castaneda A, Jimenez-Corona A, Kahuam-Lopez N, Ramirez-Miranda A, Navas A, Graue-Hernandez EO. Comparison of mini-simple limbal epithelial transplantation and conjunctival-limbal autograft for the treatment of primary pterygium: a randomised controlled trial. Br J Ophthalmol. 2023 Nov 22;107(12):1776-1781. doi: 10.1136/bjo-2021-320707.

    PMID: 37739769DERIVED

MeSH Terms

Conditions

Pterygium Of Conjunctiva And Cornea

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 6, 2017

Study Start

September 17, 2015

Primary Completion

November 17, 2016

Study Completion

November 28, 2017

Last Updated

March 9, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Patient data will be analyzed by a single researcher