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

Study Overview
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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.

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

Conditions
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Myopia

Intervention / Treatment
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* Procedure: Implantable Collamer Lens (ICL)
* Procedure: Implantable Intraocular Lens (IPCL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: myopia of more than 6 diopter Exclusion Criteria: unstable refraction unstable refraction

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Implantable Collamer Lens (ICL)<br> | Procedure: Implantable Collamer Lens (ICL)<br>* 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<br>|
| Active Comparator: Implantable Intraocular Lens (IPCL)<br> | Procedure: Implantable Intraocular Lens (IPCL)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UCVA | Uncorrected Visual Acuity measured in decimal | Baseline | 
| UCVA | Uncorrected Visual Acuity measured in decimal | 3 months postoperative | 
| UCVA | Uncorrected Visual Acuity measured in decimal | 6 months postoperative | 
| UCVA | Uncorrected Visual Acuity measured in decimal | 12 months postoperative | 
| BCVA | Best corrected Visual Acuity measured in decimal | Baseline | 
| BCVA | Best corrected Visual Acuity measured in decimal | 3 months postoperative | 
| BCVA | Best corrected Visual Acuity measured in decimal | 6 months postoperative | 
| BCVA | Best corrected Visual Acuity measured in decimal | 12 months postoperative | 
| Refraction | Preoperative refractive error measured in spherical equivalent | Baseline | 
| Refraction | postoperative refractive error measured in spherical equivalent | 3 months postoperative | 
| Refraction | postoperative refractive error measured in spherical equivalent | 6 months postoperative | 
| Refraction | postoperative refractive error measured in spherical equivalent | 12 months postoperative |