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CompletedNCT05585736Updated Oct 19, 2022

Cycloplegia and Refractive Status

An interventional study of Cycloplegics in Cycloplegia, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2022-10-19.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Sep 2021, registered Sep 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
388
Allocation
Not applicable
Ages
2 Years to 10 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cycloplegia
03

In context

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Unwilling to participate in the study.
  • Previous ocular surgery
  • Any diagnosed ocular disease
  • History of ocular trauma
  • Irregular astigmatism on corneal topography.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
388 participants (actual)

Study arms

  • Other
    Cycloplegic refraction

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

    Drug: Cycloplegics

Interventions

  • DrugCycloplegics

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline

  2. 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

    Time frame: Immediate after 30 minutes of cycloplegic addition

  3. 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.

    Time frame: Baseline

  4. 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

    Time frame: Immediate after 30 minutes after cycloplegia

07

Study locations

1 site
  • Ehab tharwat
    Damieta, New Damietta 34517, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05585736
Lead sponsor
Al-Azhar University
Responsible party
Ehab tharwat (Principal Investigator, Al-Azhar University) — Principal investigator
First posted
Oct 19, 2022
Start date
Sep 20, 2021
Primary completion
Sep 1, 2022
Completion
Sep 15, 2022
Last update
Oct 19, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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