NCT05812508

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).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

March 4, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

March 4, 2023

Last Update Submit

April 2, 2023

Conditions

Keywords

pterygium surgery by bare scleral & autograft

Outcome Measures

Primary Outcomes (2)

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

    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.

    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

Study Arms (2)

pterygium surgery with bare scleral technique

corneal topograghy before and after surgery

Device: corneal topography

pterygium surgery with conjunctival autograft technique

corneal topograghy before and after surgery

Device: corneal topography

Interventions

corneal topography before and after pterygium surgery by two techniques bare scleral and conjunctival autograft

pterygium surgery with bare scleral techniquepterygium surgery with conjunctival autograft technique

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yilmaz S, Yuksel T, Maden A. Corneal topographic changes after four types of pterygium surgery. J Refract Surg. 2008 Feb;24(2):160-5. doi: 10.3928/1081597X-20080201-06.

    PMID: 18297940BACKGROUND

MeSH Terms

Interventions

Corneal Topography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Zeinab Mahmoud Aly, bechlor

CONTACT

Alahmady Hamad Elsamman, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

March 4, 2023

First Posted

April 13, 2023

Study Start

April 20, 2023

Primary Completion

August 1, 2023

Study Completion

October 1, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04