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Completed

NCT Number: NCT07742995

Preoperative and Postoperative Refractive and Topographic Evaluation in Patients With Primary Pterygium: Comparison of Two Surgical Techniques

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Primary pterygium is a fibrovascular proliferation of the bulbar conjunctiva that extends onto the cornea and may induce significant refractive and topographic changes, resulting in visual impairment. Surgical excision is the treatment of choice for progressive lesions, with conjunctival autograft (CA) and amniotic membrane transplantation (AMT) representing two widely used techniques.

This non-randomized interventional clinical study compared refractive and corneal topographic outcomes following primary pterygium surgery using conjunctival autograft or amniotic membrane transplantation. Adult patients diagnosed with primary pterygium were allocated to one of the two surgical procedures according to clinical criteria. Preoperative and postoperative evaluations included best-corrected visual acuity, objective and subjective refraction, slit-lamp examination, and corneal topography. Patients were followed for 12 months after surgery.

The primary objective was to compare postoperative refractive and topographic changes between the two surgical techniques. Secondary objectives included evaluating changes in visual acuity, corneal curvature, refractive astigmatism, topographic astigmatism, and identifying clinical factors associated with postoperative outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Conjunctival Autograft

Procedure

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

Amniotic membrane transplantation

Procedure

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

Primary outcomes

  1. Change in Corneal Topographic Astigmatism

    Time frame: Baseline and 12 months after surgery

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

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Official study title

Preoperative and Postoperative Refractive and Topographic Evaluation in Patients With Primary Pterygium: A Comparison of Conjunctival Autograft and Amniotic Membrane Transplantation

Acronym: RETOP

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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