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Completed

NCT Number: NCT05585736

Cycloplegia and Refractive Status

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.

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Key information

Conditions

Cycloplegia

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ehab tharwat

Damietta, New Damietta, 34517, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cycloplegics

Drug

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

Primary outcomes

  1. Sphere of the eye

    Time frame: 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

  2. Sphere of the eye

    Time frame: 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

  3. cylinder of the eye

    Time frame: 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.

  4. cylinder

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Effect of Cycloplegia on the Refractive Status of Egyptian Children

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2022
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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