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New treatment option for Myopia, Moderate
Official title A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses
ClinicalTrials.gov ID: NCT06839898
What this study is testing
- What it's testing
- Primary Objective: To compare the efficacy and the residual refractive error of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patient with co-existing astigmatism. Secondary Objectives: To evaluate and compare the safety of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patients with co-existing astigmatism.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Patients 21 years old or older.
- Calculated IOL Power is within the range of the investigational IOLs
- Corneal Cylindrical error within the range defined in the clinical investigation plan
- Subject has monocular UCVA 0.5 LogMAR or worse
- Subject has had a stable refraction (±0.5D; ±1.0D for higher refractive errors), as expressed by manifest refraction spherical equivalent (MRSE) for...
You likely can't join if
- Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation.
- Subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject
- Subject with ocular condition that may predispose the subject to future complications
- Subject with previous intraocular or corneal surgery
- Subject with less than the minimum endothelial cell density 2000 cells/mm² at the time of enrollment
- Pregnant or planning to become pregnant, or is lactating during the course of the evaluation
See the full eligibility criteria
- Patients 21 years old or older.
- Calculated IOL Power is within the range of the investigational IOLs
- Corneal Cylindrical error within the range defined in the clinical investigation plan
- Subject has monocular UCVA 0.5 LogMAR or worse
- Subject has had a stable refraction (±0.5D; ±1.0D for higher refractive errors), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum 12 months prior to surgery, verified by consecutive...
- Subject, who is a current contact lens wearer, needs to demonstrate a stable refraction (±0.5D) expressed as MRSE, on two consecutive examination dates and stability of the refraction is determined by the following...
- Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction.
- Two refractions were performed at least 7 days apart.
- Subject, who is expected to have residual postoperative cylindrical refractive error of ≥1D, has been given the opportunity to experience his/her best spectacle vision with the anticipated correction.
- Expected dilated pupil size at least large enough to visualize the axis marking.
- Patients willing to attend all follow-up appointments
- Patients must sign and be given a copy of the written Informed Consent form
- Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation.
- Subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject
- Subject with ocular condition that may predispose the subject to future complications
- Subject with previous intraocular or corneal surgery
- Subject with less than the minimum endothelial cell density 2000 cells/mm² at the time of enrollment
- Pregnant or planning to become pregnant, or is lactating during the course of the evaluation
- Other condition associated with fluctuation of hormones
- ACD measured from the endothelium lower than 2.8 mm
- Concurrent participation in another drug or device evaluation.
- Any cataract of any grade.
- Coefficient of variation of endothelial cell area \>0.45
- Percent Hexagonality of endothelial cell shape ≤ 45%
- Monocular subject
- Vulnerable people as defined in section 12.3.10
The study team makes the final eligibility decision.
Where it's taking place
- Münster, North Rhine-Westphalia, Germany
- Rheine, North Rhine-Westphalia, Germany
- Steinfurt, North Rhine-Westphalia, Germany
- Bangalore, Karnataka, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Münster, North Rhine-Westphalia, Germany; Rheine, North Rhine-Westphalia, Germany; Steinfurt, North Rhine-Westphalia, Germany; Bangalore, Karnataka, India. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.