Comparing two types of implantable lenses for correcting myopia and astigmatism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: bhargav.joshi@biotechhealthcare.com
• Phone: 917966823000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing two trifocal toric intraocular lenses for cataract surgery.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.