NCT05026307

Brief Summary

The purpose of the study is to assess the corneal topographic changes after primary pterygium surgery

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

August 22, 2021

Last Update Submit

August 25, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in corneal topography

    Detection of changes in corneal topography using Pentacam

    One month, three and six months postoperative

Study Arms (1)

Pterygium

EXPERIMENTAL

Simple surgical excision of pterygium withe bare sclera

Procedure: Excision of pterygium

Interventions

Simple surgical excision of pterygium with bare sclera

Pterygium

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with primary pterygium

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag

Sohag, 82511, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 24324789BACKGROUND
  • 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.

    PMID: 6712914BACKGROUND
  • 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.

    PMID: 15094131BACKGROUND
  • 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.

    PMID: 29184086BACKGROUND

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Central Study Contacts

Sara a abdel raheem, resident

CONTACT

Gamal A Radwan, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

August 22, 2021

First Posted

August 30, 2021

Study Start

June 15, 2021

Primary Completion

December 1, 2021

Study Completion

February 1, 2022

Last Updated

August 30, 2021

Record last verified: 2021-08

Locations