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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05812508
Collaborator
(none)
30
5.4

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Device: corneal topography

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Comparative Study Between Bare Scleral Technique and Conjunctival Autograft on Corneal Topography After Pterygium Surgery
Anticipated Study Start Date :
Apr 20, 2023
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. comparison of topography finding after pterygium surgery by the bare scleral technique. [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.

  2. comparison of topography finding after pterygium surgery by the conjunctival auto-graft technique. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zainab Mahmoud Ali, resident, Sohag University
ClinicalTrials.gov Identifier:
NCT05812508
Other Study ID Numbers:
  • Soh-Med-22-10-02
First Posted:
Apr 13, 2023
Last Update Posted:
Apr 13, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zainab Mahmoud Ali, resident, Sohag University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2023