Corneal Topographic Changes After Pterygium Surgery
Primary Purpose
Pterygium
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Excision of pterygium
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium
Eligibility Criteria
Inclusion Criteria:
- patients with primary pterygium
Exclusion Criteria:
- patients with recurrent pterygium
- patients with primary pterygium with other ocular pathologies.
Sites / Locations
- SohagRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pterygium
Arm Description
Simple surgical excision of pterygium withe bare sclera
Outcomes
Primary Outcome Measures
Changes in corneal topography
Detection of changes in corneal topography using Pentacam
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05026307
Brief Title
Corneal Topographic Changes After Pterygium Surgery
Official Title
Corneal Topographic Changes After Pterygium Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
February 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of the study is to assess the corneal topographic changes after primary pterygium surgery
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pterygium
Arm Type
Experimental
Arm Description
Simple surgical excision of pterygium withe bare sclera
Intervention Type
Procedure
Intervention Name(s)
Excision of pterygium
Intervention Description
Simple surgical excision of pterygium with bare sclera
Primary Outcome Measure Information:
Title
Changes in corneal topography
Description
Detection of changes in corneal topography using Pentacam
Time Frame
One month, three and six months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with primary pterygium
Exclusion Criteria:
patients with recurrent pterygium
patients with primary pterygium with other ocular pathologies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara a abdel raheem, resident
Phone
01153987387
Email
saraalalem2020@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gamal A Radwan, professor
Facility Information:
Facility Name
Sohag
City
Sohag
ZIP/Postal Code
82511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R ElSherif, professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24324789
Citation
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.
Results Reference
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PubMed Identifier
6712914
Citation
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.
Results Reference
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PubMed Identifier
15094131
Citation
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.
Results Reference
background
PubMed Identifier
29184086
Citation
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.
Results Reference
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Corneal Topographic Changes After Pterygium Surgery
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