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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06058780
• Other study ID #: ICL vs IPCL
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 25 Years

Eligibility

Inclusion Criteria:

• myopia of more than 6 diopter

Exclusion Criteria:

• unstable refraction

• unstable refraction

Related Conditions & MeSH terms

• Myopia

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Akram Fekry Elgazzar	Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UCVA	Uncorrected Visual Acuity measured in decimal	Baseline
Primary	UCVA	Uncorrected Visual Acuity measured in decimal	3 months postoperative
Primary	UCVA	Uncorrected Visual Acuity measured in decimal	6 months postoperative
Primary	UCVA	Uncorrected Visual Acuity measured in decimal	12 months postoperative
Primary	BCVA	Best corrected Visual Acuity measured in decimal	Baseline
Primary	BCVA	Best corrected Visual Acuity measured in decimal	3 months postoperative
Primary	BCVA	Best corrected Visual Acuity measured in decimal	6 months postoperative
Primary	BCVA	Best corrected Visual Acuity measured in decimal	12 months postoperative
Primary	Refraction	Preoperative refractive error measured in spherical equivalent	Baseline
Primary	Refraction	postoperative refractive error measured in spherical equivalent	3 months postoperative
Primary	Refraction	postoperative refractive error measured in spherical equivalent	6 months postoperative
Primary	Refraction	postoperative refractive error measured in spherical equivalent	12 months postoperative