NCT06596408

Brief Summary

Study aiming to evaluate Macular Vascular Density in High Myopes without pathological myopic maculopathy in outpatient clinic in Sohag teaching hospital using OCTA .

Trial Health

57
Monitor

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 not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
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

August 30, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

September 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

12 months

First QC Date

August 30, 2024

Last Update Submit

September 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Outcome of evaluation of vascular density in high myopes

    Correlation between macular vascular density in high myopes and their : Uncorrected visual acuity in diopters . Best corrected visual acuity in diopters . Spherical equivalent refraction that measured through this equivalent (spherical error + 1/2 cylindrical error ) . Central macular thickness in micrometers . To see how does ischemia affects vision in high myopes .

    6 month

Study Arms (1)

High Myopes of spherical error -6 and more .

EXPERIMENTAL

About 50 participants with high myopia will undergo evaluation of their macular vascular density using OCTA and also central macular thickness using OCT.

Other: optical coherence tomography angiography

Interventions

OCTA will be used to evaluate the macular vascular density and to exclude patients with pathological myopic maculopathy

High Myopes of spherical error -6 and more .

Eligibility Criteria

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

You may qualify if:

  • All myopic patients with axial high myopia (-6 spherical refractive error or more) of different age groups .

You may not qualify if:

  • History of other any ocular diseases , systemic diseases that may affect the ocular circulation .
  • Previous intraocular surgery or ocular injury .
  • Any patient with pathological myopic maculopathy as epiretinal membrane, foveoschisis, macular holes, lamellar holes, Lacquers cracks, choroidal neovascularization and retinal atrophy .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Sohag Governorate, 82524, Egypt

RECRUITING

Study Officials

  • Adham Salah Mohammed, lecturer

    Sohag University

    STUDY CHAIR

Central Study Contacts

Sara Magdy Mohammed, Master degree

CONTACT

Islam Awny Ahmed, Ass. Prof

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 30, 2024

First Posted

September 19, 2024

Study Start

September 11, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations