Back to resultsSafety and Efficacy of Implantable Collamer Lens Versus Implantable Phakic Lens IPCL in Myopic Patients; A Comparative Study
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Implantable Collamer Lens (ICL)
Implantable Intraocular Lens (IPCL)
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria: myopia of more than 6 diopter Exclusion Criteria: unstable refraction unstable refraction
Sites / Locations
- Akram Fekry Elgazzar
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Implantable Collamer Lens (ICL)
Implantable Intraocular Lens (IPCL)
Arm Description
Outcomes
Primary Outcome Measures
UCVA
Uncorrected Visual Acuity measured in decimal
UCVA
Uncorrected Visual Acuity measured in decimal
UCVA
Uncorrected Visual Acuity measured in decimal
UCVA
Uncorrected Visual Acuity measured in decimal
BCVA
Best corrected Visual Acuity measured in decimal
BCVA
Best corrected Visual Acuity measured in decimal
BCVA
Best corrected Visual Acuity measured in decimal
BCVA
Best corrected Visual Acuity measured in decimal
Refraction
Preoperative refractive error measured in spherical equivalent
Refraction
postoperative refractive error measured in spherical equivalent
Refraction
postoperative refractive error measured in spherical equivalent
Refraction
postoperative refractive error measured in spherical equivalent
Secondary Outcome Measures
Full Information
NCT ID
NCT06058780
First Posted
September 22, 2023
Last Updated
September 22, 2023
Sponsor
Al-Azhar University
1. Study Identification
Unique Protocol Identification Number
NCT06058780
Brief Title
Safety and Efficacy of Implantable Collamer Lens Versus Implantable Phakic Lens IPCL in Myopic Patients; A Comparative Study
Official Title
Safety and Efficacy of Implantable Collamer Lens Versus Implantable Phakic Lens IPCL in Myopic Patients; A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Implantable Collamer Lens (ICL)
Arm Type
Active Comparator
Arm Title
Implantable Intraocular Lens (IPCL)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Implantable Collamer Lens (ICL)
Intervention Description
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
Intervention Name(s)
Implantable Intraocular Lens (IPCL)
Intervention Description
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 Outcome Measure Information:
Title
UCVA
Description
Uncorrected Visual Acuity measured in decimal
Time Frame
Baseline
Title
UCVA
Description
Uncorrected Visual Acuity measured in decimal
Time Frame
3 months postoperative
Title
UCVA
Description
Uncorrected Visual Acuity measured in decimal
Time Frame
6 months postoperative
Title
UCVA
Description
Uncorrected Visual Acuity measured in decimal
Time Frame
12 months postoperative
Title
BCVA
Description
Best corrected Visual Acuity measured in decimal
Time Frame
Baseline
Title
BCVA
Description
Best corrected Visual Acuity measured in decimal
Time Frame
3 months postoperative
Title
BCVA
Description
Best corrected Visual Acuity measured in decimal
Time Frame
6 months postoperative
Title
BCVA
Description
Best corrected Visual Acuity measured in decimal
Time Frame
12 months postoperative
Title
Refraction
Description
Preoperative refractive error measured in spherical equivalent
Time Frame
Baseline
Title
Refraction
Description
postoperative refractive error measured in spherical equivalent
Time Frame
3 months postoperative
Title
Refraction
Description
postoperative refractive error measured in spherical equivalent
Time Frame
6 months postoperative
Title
Refraction
Description
postoperative refractive error measured in spherical equivalent
Time Frame
12 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
myopia of more than 6 diopter
Exclusion Criteria:
unstable refraction
unstable refraction
Facility Information:
Facility Name
Akram Fekry Elgazzar
City
Damietta
ZIP/Postal Code
34517
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Implantable Collamer Lens Versus Implantable Phakic Lens IPCL in Myopic Patients; A Comparative Study
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