NCT05585736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
388

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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 20, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 19, 2022

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

September 17, 2022

Last Update Submit

October 14, 2022

Conditions

Cycloplegia

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Cycloplegic refraction

OTHER

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

Drug: Cycloplegics

Interventions

CycloplegicsDRUG

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

Cycloplegic refraction

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ehab tharwat

Damietta, New Damietta, 34517, Egypt

Location

MeSH Terms

Interventions

Mydriatics

Intervention Hierarchy (Ancestors)

Autonomic AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Design

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

Study Record Dates

First Submitted

September 17, 2022

First Posted

October 19, 2022

Study Start

September 20, 2021

Primary Completion

September 1, 2022

Study Completion

September 15, 2022

Last Updated

October 19, 2022

Record last verified: 2022-10

Locations

EG(1)