NCT03304366

Brief Summary

Aim of this study is to assess the corneal changes before and after pterygium excision by using pentacam system.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

October 4, 2017

Last Update Submit

October 4, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pentacam analysis.

    Corneal changes such as thickness and elevations

    preoperative and then will be followed up 2 and 6 months post pterygium excision.

Study Arms (1)

Patients with primary pterygium

* 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.

Diagnostic Test: Pentacam (scheimpflug imaging)

Interventions

Corneal changes including thickness, elevations....etc

Patients with primary pterygium

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with primary pterygium comes to Assiut University Hospital, Assiut Police Hospital, Private clinic They will perform the Pentacam analysis at Assuit Eye research centers (Alforsan-Elnoor)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Study Officials

  • Mohammed S Abdelrahman, Prof

    Assiut University

    STUDY CHAIR

Central Study Contacts

Mohammed G Abdelsalam, MBBCH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 9, 2017

Study Start

November 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

October 9, 2017

Record last verified: 2017-10