A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia, Degenerative; Myopic Astigmatism; Myopia, Moderate
• Intervention / Treatment: Device: EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm; Device: Visian® Toric ICL Treatment Arm

Detailed Description

Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism.1

• Study Type: Interventional
• Enrollment (Estimated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BHARGAV D JOSHI, M.Sc.; Phone Number: 203 917966823000; Email: bhargav.joshi@biotechhealthcare.com
• Study Contact Backup: Name: Hatice B Deveci Summer, B.Sc; Phone Number: 0491739106424; Email: basak.deveci@biotechhealthcare.com

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Münster, Nordrhein-Westfalen, Germany, 48268
      • Recruiting
      • Precise Vision Augentagesklinik Greven
      • Contact: Clinical Study Coordinator, Optometrist; Phone Number: 0049 0 800 3 100 900; Email: e.diepenbrock@precisevision.de
    • Rheine, Nordrhein-Westfalen, Germany, 48429
      • Recruiting
      • Precise Vision Augentagesklinik Rheine
      • Contact: Clinical Study Coordinator, optometrist; Phone Number: 0049 0 800 3 100 900; Email: a.gerling@precise.vision
    • Steinfurt, Nordrhein-Westfalen, Germany, 48429
      • Recruiting
      • Precise Vision Augentagesklinik Rheine
      • Contact: Clinical Study Coordinator, optometrist; Phone Number: 0049 0 800 3 100 900; Email: a.gerling@precise.vision
• India
  • Karnataka
    • Bangalore, Karnataka, India, 560 082
      • Recruiting
      • Netradhama Superspeciality Eye Hospital
      • Contact: Clinical Study Coordinator, MsC.; Phone Number: 009196 935 01981; Email: research@nethradhama.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm; Patients will be implanted with Eyecryl Phakic Toric IOL based on randomization.	Device: EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm; The patients will be implanted with Eyecryl Phakic IOL at this arm based on randomization.Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism.
Active Comparator: Visian® Toric ICL Treatment Arm; Patients will be implanted with Visian® Toric ICL based on randomization.	Device: Visian® Toric ICL Treatment Arm; The patients will be implanted with Visian® Toric Implantable Contact Lens at this arm based on randomization. Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mean residual refractive error	The mean residual refractive error in the study lens population that is equivalent to the mean residual refractive error of the control lens within +/- 0.50 Diopters at the 6-months post-op visit.	6 Month

Collaborators and Investigators

• Sponsor: Biotech Healthcare Holding Gmbh

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2021
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Astigmatism; Myopia, Degenerative
• Other Study ID Numbers: BTVCPL-PHAKICTORIC-2019-13; CIV- 20-09-034764 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No