- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05026307
Corneal Topographic Changes After Pterygium Surgery
August 25, 2021 updated by: Sara Ahmed Abdelraheem, Sohag University
The purpose of the study is to assess the corneal topographic changes after primary pterygium surgery
Study Overview
Detailed Description
Prospective interventional comparative study . This study will be conducted on eyes with primary pterygium before and after successful excision in department of ophthalmology, Sohag university hospital to assess the corneal topographic changes using pentacam .
Postoperative evaluation will be scheduled for one month ,three and six months postoperative.
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Not Applicable
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
- Name: Sara a abdel raheem, resident
- Phone Number: 01153987387
- Email: saraalalem2020@yahoo.com
Study Contact Backup
- Name: Gamal A Radwan, professor
Study Locations
-
-
-
Sohag, Egypt, 82511
- Recruiting
- Sohag
-
-
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
20 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with primary pterygium
Exclusion Criteria:
- patients with recurrent pterygium
- patients with primary pterygium with other ocular pathologies.
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
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Pterygium
Simple surgical excision of pterygium withe bare sclera
|
Simple surgical excision of pterygium with bare sclera
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in corneal topography
Time Frame: One month, three and six months postoperative
|
Detection of changes in corneal topography using Pentacam
|
One month, three and six months postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nangia V, Jonas JB, Nair D, Saini N, Nangia P, Panda-Jonas S. Prevalence and associated factors for pterygium in rural agrarian central India. The central India eye and medical study. PLoS One. 2013 Dec 4;8(12):e82439. doi: 10.1371/journal.pone.0082439. eCollection 2013.
- Moran DJ, Hollows FC. Pterygium and ultraviolet radiation: a positive correlation. Br J Ophthalmol. 1984 May;68(5):343-6. doi: 10.1136/bjo.68.5.343.
- Di Girolamo N, Chui J, Coroneo MT, Wakefield D. Pathogenesis of pterygia: role of cytokines, growth factors, and matrix metalloproteinases. Prog Retin Eye Res. 2004 Mar;23(2):195-228. doi: 10.1016/j.preteyeres.2004.02.002.
- Xu Z, Li W, Jiang J, Zhuang X, Chen W, Peng M, Wang J, Lu F, Shen M, Wang Y. Characteristic of entire corneal topography and tomography for the detection of sub-clinical keratoconus with Zernike polynomials using Pentacam. Sci Rep. 2017 Nov 28;7(1):16486. doi: 10.1038/s41598-017-16568-y.
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 (ACTUAL)
June 15, 2021
Primary Completion (ANTICIPATED)
December 1, 2021
Study Completion (ANTICIPATED)
February 1, 2022
Study Registration Dates
First Submitted
August 22, 2021
First Submitted That Met QC Criteria
August 25, 2021
First Posted (ACTUAL)
August 30, 2021
Study Record Updates
Last Update Posted (ACTUAL)
August 30, 2021
Last Update Submitted That Met QC Criteria
August 25, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-21-06-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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