NCT07742995

Brief Summary

This study evaluated changes in refractive status and corneal topography before and after surgical treatment of primary pterygium. Patients undergoing pterygium excision were treated with either conjunctival autograft or amniotic membrane transplantation. Visual acuity, refractive error, and corneal topographic parameters were assessed before surgery and after postoperative follow-up to compare the effectiveness of both surgical techniques in restoring corneal optics and improving visual outcomes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

1.9 years

First QC Date

July 29, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

Primary PterygiumConjunctival AutograftAmniotic Membrane TransplantationCorneal Topography

Outcome Measures

Primary Outcomes (1)

  • Change in Corneal Topographic Astigmatism

    Comparison of the change in corneal topographic astigmatism from baseline to 12 months after pterygium excision between conjunctival autograft and amniotic membrane transplantation.

    Baseline and 12 months after surgery

Study Arms (2)

Conjunctival Autograft

EXPERIMENTAL

Participants with primary pterygium underwent pterygium excision followed by conjunctival autograft transplantation. Postoperative refractive status, visual acuity, and corneal topographic outcomes were evaluated during a 12-month follow-up.

Procedure: Conjunctival Autograft

Amniotic Membrane Transplantation

EXPERIMENTAL

Participants with primary pterygium underwent pterygium excision followed by amniotic membrane transplantation. Postoperative refractive status, visual acuity, and corneal topographic outcomes were evaluated during a 12-month follow-up.

Procedure: Amniotic Membrane Transplantation

Interventions

Surgical excision of primary pterygium followed by transplantation of an autologous superior temporal conjunctival graft to cover the bare scleral bed.

Conjunctival Autograft

Surgical excision of primary pterygium followed by placement of preserved amniotic membrane over the bare scleral bed.

Amniotic Membrane Transplantation

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 years or older.
  • Diagnosis of primary nasal pterygium in one or both eyes.
  • Pterygium extending at least 1 mm onto the cornea.
  • Candidate for surgical treatment and willing to undergo pterygium excision.

You may not qualify if:

  • Corneal scars.
  • Corneal ectatic disorders.
  • History of ocular trauma.
  • Previous ocular surgery.
  • Cicatrizing ocular surface disease.
  • Cataract or any other ocular condition that could affect visual function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants with primary pterygium were assigned to one of two parallel intervention groups according to clinical and surgical criteria. One group underwent conjunctival autograft, and the other underwent amniotic membrane transplantation. Outcomes were compared after a 12-month follow-up.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 3, 2026

Study Start

April 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

August 3, 2026

Record last verified: 2026-07