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

NCT ID: NCT06058780

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Implantable Collamer Lens (ICL)

Group Type ACTIVE_COMPARATOR

Implantable Collamer Lens (ICL)

Intervention Type 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)

Group Type ACTIVE_COMPARATOR

Implantable Intraocular Lens (IPCL)

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* myopia of more than 6 diopter

Exclusion Criteria

* unstable refraction
* unstable refraction
Minimum Eligible Age

20 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Akram Fekry Elgazzar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Akram Fekry Elgazzar

Damietta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ICL vs IPCL

Identifier Type: -

Identifier Source: org_study_id

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