Comparison Between Bare Scleral Technique and Conjunctival Auto-graft on Corneal Topography After Pterygium Surgery

April 2, 2023 updated by: Zainab Mahmoud Ali, Sohag University

A Comparative Study Between Bare Scleral Technique and Conjunctival Autograft on Corneal Topography After Pterygium Surgery

Aim of the work:

To study the corneal topographic pattern changes in patients who have pterygium excision by two surgical techniques (bare sclera, conjunctival autograft).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pterygium is one of the common ocular surface disorders , it's is an elastotic triangular fibro-vascular tissue covered by conjunctival epithelium that spreads over the cornea. Pterygium causes differences in curvature & power across the cornea .

The prevalence of pterygium varies from 1.1% to 53% globally in different environmental conditions. Risk factors include;UV radiation, geographical latitude near to the equator, outdoor activity , aging, male, and dusty environment.

Pterygium excision is important in patients suffering from blurred vision due to astigmatism . Surgical techniques include ; bare sclera excision, conjunctival autograft, conjunctival transpositional flap, and amniotic membrane grafting. Pterygium excision increases in the mean central corneal curvature & reduces astigmatism that leads to improvement in visual acuity.

Corneal topography is a gold standard in corneal pathology follow-up. Corneal topography is a computer assisted diagnostic tool that creates a three-dimensional map of the surface curvature of the cornea. Corneal topography produces a detailed, visual description of the shape and power of the cornea.

In this study , corneal topography is used to detect how does corneal curvature change after excision of pterygium .

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Alahmady Hamad Elsamman, MD
  • Phone Number: 01111102698

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with pterygium not associated with other pathologies in the eye (suitable for excision) .

Description

Inclusion Criteria:-

  • Patients with pterygium not associated with other pathologies (suitable for excision).
  • Nasal pterygium extended to the cornea.

Exclusion Criteria: -

  • Associated pathologies such as glaucoma, and cataract.
  • Corneal opacities or irregularities, scars, dystrophy or ectasia.
  • Patients who underwent previous corneal surgery (including refractive surgery)
  • Pseudo-pterygium.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pterygium surgery with bare scleral technique
corneal topograghy before and after surgery
Device: corneal topography
corneal topography before and after pterygium surgery by two techniques bare scleral and conjunctival autograft
pterygium surgery with conjunctival autograft technique
corneal topograghy before and after surgery
Device: corneal topography
corneal topography before and after pterygium surgery by two techniques bare scleral and conjunctival autograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of topography finding after pterygium surgery by the bare scleral technique.
Time Frame: baseline
To investigate the corneal topographic changes by imaging the corneal topography before and after pterygium excision (by the bare scleral technique); to detect corneal curvature changes.
baseline
comparison of topography finding after pterygium surgery by the conjunctival auto-graft technique.
Time Frame: baseline
To investigate the corneal topographic changes by imaging the corneal topography before and after pterygium excision (by the conjunctival auto-graft technique); to detect corneal curvature changes.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 20, 2023

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

March 4, 2023

First Submitted That Met QC Criteria

April 2, 2023

First Posted (Estimate)

April 13, 2023

Study Record Updates

Last Update Posted (Estimate)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-10-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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