Corneal Topographic Changes After Pterygium Surgery | NCT05026307

Studies
Corneal Topographic Changes After Pterygium Surgery

NCT05026307

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Aug 30, 2021Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Pterygium

Interventions

Excision of pterygium

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2021Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Feb 2022Estimated

First Submitted Date

Aug 22, 2021

First Submission Date that Met QC Criteria

Aug 25, 2021

First Posted Date

Aug 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2021

Last Update Posted Date

Aug 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pterygium	Experimental	Simple surgical excision of pterygium withe bare sclera	Procedure: Excision of pterygium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Excision of pterygium	Procedure	Simple surgical excision of pterygium with bare sclera	Pterygium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in corneal topography	Detection of changes in corneal topography using Pentacam	One month, three and six months postoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with primary pterygium

Exclusion Criteria:

patients with recurrent pterygium
patients with primary pterygium with other ocular pathologies.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sara a abdel raheem, resident	Contact	01153987387		saraalalem2020@yahoo.com
Gamal A Radwan, professor	Contact

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag	Recruiting	Sohag		82511	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24324789	Background	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.
6712914	Background	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.

Type	Date	Date Unknown
Release	Dec 7, 2022
Unrelease	Dec 20, 2022
Release	Dec 20, 2022
Reset	Oct 20, 2023

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 7, 2022	Dec 20, 2022
Dec 20, 2022

ID	Term
D003229	Conjunctival Diseases
D005128	Eye Diseases