Actively Recruiting
A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses to Compare Outcomes in Patients With Moderate to High Myopia and Astigmatism
Led by Biotech Healthcare Holding Gmbh · Updated on 2025-02-21
172
Participants Needed
4
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness and remaining refractive error of two types of phakic toric intraocular lenses in patients with moderate to high myopia and astigmatism. The study also evaluates and compares the safety of the EYECRYLTM Phakic Toric lens versus the Visian4 Toric Implantable Contact Lens in this patient group. Phakic intraocular lenses are clear lenses surgically placed in the eye without removing the natural lens, helping to improve uncorrected vision by focusing light correctly on the retina. Participants will be randomly assigned to receive one of two treatments: the Eyecryl Phakic Toric intraocular lens or the Visian4 Toric Implantable Contact Lens. Both lenses are designed to correct myopia and astigmatism and are implanted either in the anterior or posterior chamber of the eye. The study involves surgical placement of these lenses to assess their performance and safety over time. During the study, participants will attend all scheduled follow-up visits to monitor visual outcomes and safety. Researchers will measure the mean residual refractive error six months after lens implantation as the primary outcome. Safety assessments and other evaluations will also be conducted to track the lenses' effects. The study started in October 2021 and is expected to continue until February 2027, with ongoing monitoring of participants' vision and eye health.
CONDITIONS
Brief 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 is within the range of the investigational IOLs
- Corneal Cylindrical error within the range defined in the clinical investigation plan
- Monocular uncorrected visual acuity (UCVA) 0.5 LogMAR or worse
- Stable refraction (±0.5D; ±1.0D for higher refractive errors) for at least 12 months prior to surgery
- Contact lens wearers must show stable refraction (±0.5D) on two consecutive exams with at least 7 days apart and no contact lens use for at least 2 weeks or 3 days before first refraction
- Expected residual postoperative cylindrical refractive error of ≥1D must have experienced best spectacle vision with anticipated correction
- Expected dilated pupil size large enough to visualize the axis marking
- Willingness to attend all follow-up appointments
- Signed and provided informed consent form
You will not qualify if you...
- Acute or chronic disease increasing operative risk or confounding outcomes
- Use of systemic medication that may affect study results or increase risk
- Ocular conditions predisposing to future complications
- Previous intraocular or corneal surgery
- Endothelial cell density less than 2000 cells/mm² at enrollment
- Pregnant, planning pregnancy, or lactating during the study
- Conditions causing hormonal fluctuations
- Anterior chamber depth less than 2.8 mm measured from the endothelium
- Participation in another drug or device study
- Presence of any cataract
- Coefficient of variation of endothelial cell area greater than 0.45
- Percent hexagonality of endothelial cell shape less than or equal to 45%
- Monocular subjects
- Vulnerable subjects as defined in section 12.3.10
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo surgical implantation of a phakic toric intraocular lens to improve uncorrected visual acuity by correcting myopia and astigmatism.
1 surgical visit
Duration - 6 months
Participants are monitored after surgery to assess outcomes and ensure proper recovery.
Approximately 6 post-operative visits
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.
H
Hatice B Deveci Summer, B.Sc
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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