Corneal Changes With Pentacam Before and After Pterygium

October 4, 2017 updated by: Mohamed Gamal, Assiut University

The Use of Pentacam in Assessment of Corneal Changes After Pterygium Excision

Aim of this study is to assess the corneal changes before and after pterygium excision by using pentacam system.

Study Overview

Status

Unknown

Conditions

Detailed Description

Pterygium is a dysplasia of the bulbar conjunctiva extending onto the corneal surface. The prevelance of pterygium ranges from 0.7% to 31% in various populations according to the location, altitude, and race. It has a higher prevelance in areas which have increased exposure to direct sun with ultraviolet (UV) B light. Patients with pterygia present with variety of complaints ,ranging from asymptomatic to significant redness ,swelling ,itching ,irritation and blurring of vision associated with elevated lesions of the conjunctiva and contiguous cornea in one or both eyes.The induction of astigmatism due to the invasion of the pterygium into the cornea as well as changes in corneal curvature and refractive status has been reported by numerous studies.

Multiple different procedures have been advocated in the treatment of pterygia. These procedures range from simple excision to sliding flaps of conjunctiva with or without adjunctive external beta radiation therapy and/or use of topical chemotherapeutic agents, such as Mitomycin C.

Pentacam is a rotating Scheimpflug camera which measures Scheimpflug images of the anterior eye segment. With the pentacam, topographic analysis of the corneal front and back surfaces is based on the true elevation measurement from one side of the cornea to the other (limbus to limbus). Pentacam also describes the true thickness of the cornea across its entire breadth and width.

Type of the study: prospective observational longitudinal study

Study Setting: Assuit University Hospital ( ophthalmology Department ) Assuit Police Hospital ( ophthalmology Department )

Study subjects:

  1. Inclusion criteria:

    • The study will include 30 eyes of adult subjects.
    • All eyes have primary pterygium and seeking for surgery due to Cosmetic problems, ocular irritation, and, or visual impairment.
    • All selected patients will undergo complete ophthalmological examination including refraction, best corrected visual acuity, keratometry, and pentacam (scheimpflug imaging) preoperatively then will be followed up 2 and 6 months post pterygium excision.
  2. Exclusion criteria:

    • patients with recurrent pterygium.
    • Patients with media opacities:

      • Dense cataract. - Corneal opacities.
    • Patients with a history of intraocular surgery ,ocular trauma ,and contact lens wear.
    • Patients with severe ocular surface disorders as Stevens-Johnson syndrome.

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

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with primary pterygium comes to Assiut University Hospital, Assiut Police Hospital, Private clinic They will perform the Pentacam analysis at Assuit Eye research centers (Alforsan-Elnoor)

Description

Inclusion Criteria:

  • All eyes have primary pterygium and seeking for surgery due to Cosmetic problems, ocular irritation, and, or visual impairment.
  • All selected patients will undergo complete ophthalmological examination including refraction, best corrected visual acuity, keratometry, and pentacam (scheimpflug imaging) preoperatively then will be followed up 2 and 6 months post pterygium excision.

Exclusion Criteria:

  • patients with recurrent pterygium.
  • Patients with media opacities: Dense cataract, Corneal opacities.
  • Patients with a history of intraocular surgery ,ocular trauma ,and contact lens wear.
  • Patients with severe ocular surface disorders as Stevens-Johnson syndrome.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with primary pterygium
  • All eyes have primary pterygium and seeking for surgery due to Cosmetic problems, ocular irritation, and, or visual impairment.
  • All selected patients will undergo complete ophthalmological examination including refraction, best corrected visual acuity, keratometry, and pentacam (scheimpflug imaging) preoperatively then will be followed up 2 and 6 months post pterygium excision.
Corneal changes including thickness, elevations....etc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pentacam analysis.
Time Frame: preoperative and then will be followed up 2 and 6 months post pterygium excision.
Corneal changes such as thickness and elevations
preoperative and then will be followed up 2 and 6 months post pterygium excision.

Collaborators and Investigators

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

Investigators

  • Study Chair: Mohammed S Abdelrahman, Prof, Assiut University

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)

November 1, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 4, 2017

First Posted (Actual)

October 9, 2017

Study Record Updates

Last Update Posted (Actual)

October 9, 2017

Last Update Submitted That Met QC Criteria

October 4, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pentacam

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Sharing the results for other researchers

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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