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Corneal Changes With Pentacam Before and After Pterygium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03304366
Recruitment Status : Unknown
Verified October 2017 by Mohamed Gamal, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : October 9, 2017
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Gamal, Assiut University

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

Condition or disease Intervention/treatment
Pterygium Diagnostic Test: Pentacam (scheimpflug imaging)

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Pentacam in Assessment of Corneal Changes After Pterygium Excision
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

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.
Diagnostic Test: Pentacam (scheimpflug imaging)
Corneal changes including thickness, elevations....etc




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304366


Contacts
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Contact: Mohammed G Abdelsalam, MBBCH 01111188664 ext 002 drmoh_gamal85@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Mohammed S Abdelrahman, Prof Assiut University

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Responsible Party: Mohamed Gamal, Resident Physician, Assiut University
ClinicalTrials.gov Identifier: NCT03304366    
Other Study ID Numbers: Pentacam
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Sharing the results for other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pterygium
Conjunctival Diseases
Eye Diseases