NCT05626075

Brief Summary

To evaluate corneal topographic pattern \& its correlation with refractive status of the eye .

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

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

September 22, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

October 12, 2022

Last Update Submit

November 18, 2022

Conditions

Keywords

Topographicvisual acuity

Outcome Measures

Primary Outcomes (4)

  • Thickness

    Topographic values using Oculus Pentacam®

    3 months after begin of study

  • degree of astigmatism in D

    Topographic values using Oculus Pentacam®

    3 months after begin of study

  • maximum keratometry

    Topographic values using Oculus Pentacam®

    3 months after begin of study

  • front and back elevation of the apex (um).

    Topographic values using Oculus Pentacam®

    3 months after begin of study

Study Arms (4)

group Low Myopia

EXPERIMENTAL

1. Patients with low myopia aging more than 15 years old 2. All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction). 3. There is no restrictions on the range and regularity of keratometry

Diagnostic Test: Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.

group high myopia

EXPERIMENTAL

1. Patients with high myopia aging more than 15 years old 2. All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction). 3. There is no restrictions on the range and regularity of keratometry

Diagnostic Test: Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.

group Hypermetropia

EXPERIMENTAL

1. Patients with hypermetropia aging more than 15 years old 2. All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction). 3. There is no restrictions on the range and regularity of keratometry

Diagnostic Test: Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.

group mixed astigmatism

EXPERIMENTAL

1. Patients with mixed astigmatism aging more than 15 years old 2. All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction). 3. There is no restrictions on the range and regularity of keratometry

Diagnostic Test: Using Oculus Pentacam® which is s a rotating Scheimpflug camera. The rotational measuring procedure generates Scheimpflug images in three dimensions.

Interventions

Scheimpflug imaging attains a wide and high depth-of-focus , providing sharp images that include information from an anterior corneal surface through to the posterior crystalline capsule

Also known as: The scheimpflug principle describes the optical imaging condition
group Hypermetropiagroup Low Myopiagroup high myopiagroup mixed astigmatism

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aging more than 15 years old
  • All patients are with visual acuity (uncorrected, with habitual correction, and best spectacle correction).
  • There is no restrictions on the range and regularity of keratometry.

You may not qualify if:

  • Patients with a history of any trauma to the eye.
  • Patients with recent contact lens wear.
  • history of ocular surgery .
  • Patients with distance corrected visual acuity or abnormal retinoscopy examination (e.g., scissoring reflex).
  • \. If there was any error in reading the topographic map. 6. Patients with anemotropic refraction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultyof medicine

Sohag, 82425, Egypt

RECRUITING

Study Officials

  • Mohamed Iqbal, MD.PhD

    Sohag Faculty of medicine

    STUDY CHAIR

Central Study Contacts

Mohamed Iqbal, MD.PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmology Resident at Akhemim Central hospital

Study Record Dates

First Submitted

October 12, 2022

First Posted

November 23, 2022

Study Start

September 22, 2022

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

November 23, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations