- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03304366
Corneal Changes With Pentacam Before and After Pterygium
The Use of Pentacam in Assessment of Corneal Changes After Pterygium Excision
Study Overview
Status
Conditions
Intervention / Treatment
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:
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.
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mohammed G Abdelsalam, MBBCH
- Phone Number: 002 01111188664
- Email: drmoh_gamal85@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with primary pterygium
|
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
Sponsor
Investigators
- Study Chair: Mohammed S Abdelrahman, Prof, Assiut University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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