Comparing two types of implantable lenses for correcting myopia and astigmatism

A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses to Compare Outcomes in Patients With Moderate to High Myopia and Astigmatism

This study is testing two different types of implantable lenses to see which one helps people with moderate to high myopia and astigmatism see better without needing glasses or contacts.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 172 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Biotech Healthcare Holding Gmbh (Industry-sponsored)
• Locations: 4 sites (Münster, North Rhine-Westphalia and 3 other locations)
• Trial ID: NCT06839898 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the efficacy and safety of two types of phakic toric implantable lenses, EYECRYLTM and Visian® Toric ICL, in patients with moderate to high myopia and co-existing astigmatism. The study involves surgically placing these lenses in the eye to improve uncorrected visual acuity without removing the natural lens. Participants will be monitored for residual refractive error and overall visual outcomes following the implantation. The trial will assess both the optical quality and potential visual acuity gains provided by these lenses.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 21 and older with moderate to high myopia and astigmatism who have stable refractive errors.

Not a fit: Patients with unstable refractive errors or those who do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with improved vision correction options for myopia and astigmatism.

How similar studies have performed: Previous studies have shown promising results with phakic intraocular lenses for myopia correction, indicating that this approach is supported by existing evidence.

Eligibility criteria

Inclusion 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 refractions and/or medical records or prescription history.
* 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 criteria:

  1. Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction.
  2. 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

Exclusion Criteria:

* 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 subjects as defined in section 12.3.10

Where this trial is running

Münster, North Rhine-Westphalia and 3 other locations

• Precise Vision Augentagesklinik Greven — Münster, North Rhine-Westphalia, Germany (Recruiting)
• Precise Vision Augentagesklinik Rheine — Rheine, North Rhine-Westphalia, Germany (Recruiting)
• Precise Vision Augentagesklinik Rheine — Steinfurt, North Rhine-Westphalia, Germany (Recruiting)
• Netradhama Superspeciality Eye Hospital — Bangalore, Karnataka, India (Recruiting)

Study contacts

• Study coordinator: BHARGAV D JOSHI, M.Sc.

Conditions Myopia, Moderate; Myopic Astigmatism; Myopia, Degenerative