Cycloplegia and Refractive Status

Sponsor

Al-Azhar University (Other)

Overall Status

Completed

CT.gov ID

NCT05585736

Collaborator

(none)

388

Enrollment

Location

Arm

11.8

Actual Duration (Months)

32.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Myopia is a public health problem, affecting the general population worldwide. The common modalities for correcting myopia include spectacles, contact lenses, and surgical procedures. Cycloplegic refraction is considered the gold standard for measuring refractive errors, especially in children. It has been well-established that generally myopia could be overestimated and hyperopia be underestimated if refraction was performed without cycloplegia.

Condition or Disease	Intervention/Treatment	Phase
Cycloplegia	Drug: Cycloplegics	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

388 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Cycloplegia on the Refractive Status of Egyptian Children

Actual Study Start Date :

Sep 20, 2021

Actual Primary Completion Date :

Sep 1, 2022

Actual Study Completion Date :

Sep 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Cycloplegic refraction All refractions were measured before and after cycloplegic addition to the eye.	Drug: Cycloplegics they are drugs that paralyze the ciliary muscles and cause relaxation of accommodation.

Arm

Intervention/Treatment

Other: Cycloplegic refraction

All refractions were measured before and after cycloplegic addition to the eye.

Drug: Cycloplegics

they are drugs that paralyze the ciliary muscles and cause relaxation of accommodation.

Outcome Measures

Primary Outcome Measures

Sphere of the eye [Baseline]
It means that the correction for nearsightedness or farsightedness is spherical, equal in all meridians of the eye. This indicates the amount of lens power, measured in diopters (D), prescribed to correct nearsightedness or farsightedness. If the number appearing under this heading has a minus sign (-), you are nearsighted; if the number has a plus sign (+) or is not preceded by a plus sign or a minus sign, you are farsighted. It is measured by Auto-refractor
Sphere of the eye [Immediate after 30 minutes of cycloplegic addition]
It means that the correction for nearsightedness or farsightedness is spherical, equal in all meridians of the eye. This indicates the amount of lens power, measured in diopters (D), prescribed to correct nearsightedness or farsightedness. If the number appearing under this heading has a minus sign (-), you are nearsighted; if the number has a plus sign (+) or is not preceded by a plus sign or a minus sign, you are farsighted. It is measured by Auto-refractor
cylinder of the eye [Baseline]
This indicates the amount of lens power for astigmatism and represents the difference in the greatest and weakest powers of the eye, usually separated by 90 degrees. If nothing appears in this column, either you have no astigmatism, or your astigmatism is so slight that it is not necessary to correct it with your eyeglass lenses. The number in the cylinder column may be preceded with a minus sign (for the correction of nearsighted astigmatism) or a plus sign (for farsighted astigmatism). Cylinder power always follows sphere power in an eyeglass prescription. It is measured by Autorefractor.
cylinder [Immediate after 30 minutes after cycloplegia]
This indicates the amount of lens power for astigmatism and represents the difference in the greatest and weakest powers of the eye, usually separated by 90 degrees. If nothing appears in this column, either you have no astigmatism, or your astigmatism is so slight that it is not necessary to correct it with your eyeglass lenses. The number in the cylinder column may be preceded with a minus sign (for the correction of nearsighted astigmatism) or a plus sign (for farsighted astigmatism). Cylinder power always follows sphere power in an eyeglass prescription. It is measured by Autorefractor

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Myopia or Hyperopia or compound myopic astigmatism.
Normal intra ocular pressure (IOP≤21 mmHg.
Age > 2 years and < 10 years

Exclusion Criteria:

Unwilling to participate in the study.
Previous ocular surgery
Any diagnosed ocular disease
History of ocular trauma
Irregular astigmatism on corneal topography.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ehab tharwat	Damieta	New Damietta	Egypt	34517

Sponsors and Collaborators

Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ehab tharwat, Principal Investigator, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT05585736

Other Study ID Numbers:

Cycloplegia

First Posted:

Oct 19, 2022

Last Update Posted:

Oct 19, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mydriatics

Study Results

No Results Posted as of Oct 19, 2022