Cycloplegia and Refractive Status

Effect of Cycloplegia on the Refractive Status of Egyptian Children

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.

Study Overview

• Status: Completed
• Conditions: Cycloplegia
• Intervention / Treatment: Drug: Cycloplegics

• Study Type: Interventional
• Enrollment (Actual): 388
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • New Damietta
    • Damieta, New Damietta, Egypt, 34517
      • Ehab tharwat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sphere of the eye	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	Baseline
Sphere of the eye	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	Immediate after 30 minutes of cycloplegic addition
cylinder of the eye	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.	Baseline
cylinder	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	Immediate after 30 minutes after cycloplegia

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 20, 2021
• Primary Completion (ACTUAL): September 1, 2022
• Study Completion (ACTUAL): September 15, 2022

Study Registration Dates

• First Submitted: September 17, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (ACTUAL): October 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Mydriatics
• Other Study ID Numbers: Cycloplegia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No