NCT06484894

Brief Summary

To evaluate the impact of refractive errors on the central corneal thickness obtained by Pentacam and intraocular lenses (IOL) master in eyes with different refractive errors.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

June 26, 2024

Last Update Submit

June 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • To find if there a correlation between refractive errors and the central corneal thickness

    Study the effect of refractive errors on central corneal thickness

    Baseline

Secondary Outcomes (1)

  • To study if there a difference between measurement by pentacam and measurement of IOL master

    Baseline

Study Arms (3)

Hypermetrope

Effect of hypermetropia on central corneal thickness by using pentacam and IOL master

Device: Pentacam and IOL master

Emmetrope

Effect of emmetropia on central corneal thickness by using pentacam and IOL master

Device: Pentacam and IOL master

Myopia

Effect of myopia on central corneal thickness by using pentacam and IOL master

Device: Pentacam and IOL master

Interventions

Device used for measurement of central corneal thickness

EmmetropeHypermetropeMyopia

Eligibility Criteria

Age20 Years - 41 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

1. Inclusion criteria: Subjects included in this study aged between20 and 41 asked for refractive surgery 2. Exclusion criteria:- * Severe corneal scarrig or opacification., dystrophy * Patients with history of recent contact lens Ocular trauma. * Uveitis patients Patients with keratoconus. * Previous ocular or refractive surgey

You may qualify if:

  • Subjects included in this study aged between20 and 41 years, asked for refractive surgery

You may not qualify if:

  • patients with corneal scarrig or opacification.
  • Patients with corneal dystrophies.
  • Patients with keratoconus.
  • Previous ocular or refractive surgery.
  • Ocular trauma.
  • Uveitis patients.
  • Patients with history of recent contact lens wear.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Wang Q, Liu W, Wu Y, Ma Y, Zhao G. Central corneal thickness and its relationship to ocular parameters in young adult myopic eyes. Clin Exp Optom. 2017 May;100(3):250-254. doi: 10.1111/cxo.12485. Epub 2016 Oct 18.

    PMID: 27757993BACKGROUND
  • Prasad A, Fry K, Hersh PS. Relationship of age and refraction to central corneal thickness. Cornea. 2011 May;30(5):553-5. doi: 10.1097/ICO.0b013e3181fb880c.

    PMID: 21107245BACKGROUND

Study Officials

  • Mahmoud Fathy rateb, Professor

    Assiut University

    STUDY DIRECTOR
  • Ahmed Abd el Nasser awad, Lecturer

    Assiut University

    STUDY CHAIR
  • Mohamed Tarek Abd el menaam, Professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haidy Nayer Adly, Master

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

July 15, 2024

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

July 3, 2024

Record last verified: 2024-06