Actively Recruiting
A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses
Led by Biotech Healthcare Holding Gmbh · Updated on 2025-02-21
172
Participants Needed
4
Research Sites
277 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 21 years old or older
- Calculated IOL power within the range of the investigational IOLs
- Corneal cylindrical error within the range defined in the clinical plan
- Monocular uncorrected visual acuity (UCVA) of 0.5 LogMAR or worse
- Stable refraction (±0.5D; ±1.0D for higher errors) for at least 12 months prior to surgery
- Contact lens wearers must show stable refraction (±0.5D) on two exams at least 7 days apart, with no lens use for 2 weeks or 3 days before first refraction
- Opportunity to experience best spectacle vision if expected residual postoperative cylindrical error ≥1D
- Expected dilated pupil size sufficient to visualize axis marking
- Willingness to attend all follow-up appointments
- Signed informed consent form
You will not qualify if you...
- Acute or chronic disease increasing operative risk or affecting study outcomes
- Taking systemic medication that may affect study results or increase risk
- Ocular conditions that may cause future complications
- Previous intraocular or corneal surgery
- Endothelial cell density below 2000 cells/mm² at enrollment
- Pregnant, planning pregnancy, or lactating during study
- Hormonal fluctuation conditions
- Anterior chamber depth (ACD) less than 2.8 mm from endothelium
- Participation in another drug or device study
- Any grade of cataract
- High coefficient of variation of endothelial cell area (>0.45)
- Low percent hexagonality of endothelial cell shape (≤45%)
- Monocular vision
- Vulnerable subjects as defined in section 12.3.10
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Precise Vision Augentagesklinik Greven
Münster, North Rhine-Westphalia, Germany, 48268
Actively Recruiting
2
Precise Vision Augentagesklinik Rheine
Rheine, North Rhine-Westphalia, Germany, 48429
Actively Recruiting
3
Precise Vision Augentagesklinik Rheine
Steinfurt, North Rhine-Westphalia, Germany, 48429
Actively Recruiting
4
Netradhama Superspeciality Eye Hospital
Bangalore, Karnataka, India, 560 082
Actively Recruiting
Research Team
B
BHARGAV D JOSHI, M.Sc.
CONTACT
H
Hatice B Deveci Summer, B.Sc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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