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OpenTrials
Completed

NCT Number: NCT06058780

Safety and Efficacy of Implantable Collamer Lens Versus Implantable Phakic Lens IPCL in Myopic Patients; A Comparative Study

Phakic intraocular lenses (pIOL) have proven to be a great alternative to corneal refractive surgery in certain situations. They offer several advantages over corneal techniques, such as being suitable for high myopes and causing relatively fewer higher-order aberrations. In addition, pIOLs have been shown to provide better retinal image magnification and higher contrast sensitivity compared to laser in situ keratomileusis, regardless of whether the myopia is low or high.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

20 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akram Fekry Elgazzar

Damietta, 34517, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • myopia of more than 6 diopter

Exclusion criteria

  • unstable refraction
  • unstable refraction

Treatment and study plan

Implantable Collamer Lens (ICL)

Procedure

Phakic intraocular lenses (pIOL) have proven to be a great alternative to corneal refractive surgery in certain situations. They offer several advantages over corneal techniques, such as being suitable for high myopes and causing relatively fewer higher-order aberrations

Implantable Intraocular Lens (IPCL)

Procedure

The IPCL offers a distinct economic advantage as the cost of the IPCL implant is only 2. times that of the ICL implant. Moreover, the IPCL can correct higher degrees of myopia, up to -30. D, compared to the maximum correction of -18. D provided by the ICL.

Primary outcomes

  1. UCVA

    Time frame: Baseline

    Uncorrected Visual Acuity measured in decimal

  2. UCVA

    Time frame: 3 months postoperative

    Uncorrected Visual Acuity measured in decimal

  3. UCVA

    Time frame: 6 months postoperative

    Uncorrected Visual Acuity measured in decimal

  4. UCVA

    Time frame: 12 months postoperative

    Uncorrected Visual Acuity measured in decimal

  5. BCVA

    Time frame: Baseline

    Best corrected Visual Acuity measured in decimal

  6. BCVA

    Time frame: 3 months postoperative

    Best corrected Visual Acuity measured in decimal

  7. BCVA

    Time frame: 6 months postoperative

    Best corrected Visual Acuity measured in decimal

  8. BCVA

    Time frame: 12 months postoperative

    Best corrected Visual Acuity measured in decimal

  9. Refraction

    Time frame: Baseline

    Preoperative refractive error measured in spherical equivalent

  10. Refraction

    Time frame: 3 months postoperative

    postoperative refractive error measured in spherical equivalent

  11. Refraction

    Time frame: 6 months postoperative

    postoperative refractive error measured in spherical equivalent

  12. Refraction

    Time frame: 12 months postoperative

    postoperative refractive error measured in spherical equivalent

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2023
Registry last updated
Sep 28, 2023

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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