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

Sponsor

Al-Azhar University (Other)

Overall Status

Completed

CT.gov ID

NCT06058780

Collaborator

(none)

200

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Procedure: Implantable Collamer Lens (ICL) Procedure: Implantable Intraocular Lens (IPCL)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2021

Actual Primary Completion Date :

Aug 1, 2023

Actual Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Implantable Collamer Lens (ICL)	Procedure: Implantable Collamer Lens (ICL) 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
Active Comparator: Implantable Intraocular Lens (IPCL)	Procedure: Implantable Intraocular Lens (IPCL) 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.

Arm

Intervention/Treatment

Active Comparator: Implantable Collamer Lens (ICL)

Procedure: Implantable Collamer Lens (ICL)

Active Comparator: Implantable Intraocular Lens (IPCL)

Procedure: Implantable Intraocular Lens (IPCL)

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.

Outcome Measures

Primary Outcome Measures

UCVA [Baseline]
Uncorrected Visual Acuity measured in decimal
UCVA [3 months postoperative]
Uncorrected Visual Acuity measured in decimal
UCVA [6 months postoperative]
Uncorrected Visual Acuity measured in decimal
UCVA [12 months postoperative]
Uncorrected Visual Acuity measured in decimal
BCVA [Baseline]
Best corrected Visual Acuity measured in decimal
BCVA [3 months postoperative]
Best corrected Visual Acuity measured in decimal
BCVA [6 months postoperative]
Best corrected Visual Acuity measured in decimal
BCVA [12 months postoperative]
Best corrected Visual Acuity measured in decimal
Refraction [Baseline]
Preoperative refractive error measured in spherical equivalent
Refraction [3 months postoperative]
postoperative refractive error measured in spherical equivalent
Refraction [6 months postoperative]
postoperative refractive error measured in spherical equivalent
Refraction [12 months postoperative]
postoperative refractive error measured in spherical equivalent

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

myopia of more than 6 diopter

Exclusion Criteria:

unstable refraction
unstable refraction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akram Fekry Elgazzar	Damietta		Egypt	34517

Sponsors and Collaborators

Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Akram Fekry Elgazzar, Principal Investigator, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT06058780

Other Study ID Numbers:

ICL vs IPCL

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Sep 28, 2023