Post-market Clinical Follow-Up (PMCF) Study to Investigate Rotational Stability, Visual Performance, Contrast Sensitivity, Patient Satisfaction and PCO Rate After Implantation of a Monofocal Toric IOL
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Beaver-Visitec International, Inc.
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a single-center, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC (study no. PHY2101, ClinicalTrials.gov ID: NCT04744467)
Detailed Description
This is a single-center, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC. The device under investigation is a hydrophobic acrylic monofocal toric intraocular lens (IOL) manufactured by the sponsor of this study. The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism. If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be received an implantation with the monofocal parent lens PODEYE. The study purpose is to determine safety, rotational stability, refractive and visual performance, contrast sensitivity, patient satisfaction and PCO rate after mono- or bilateral implantation of PODEYE TORIC intraocular lens. In total approx. 15 patients will be recruited for this clinical study and undergo mono- or bilateral implantation of PODEYE TORIC intraocular lens. The maximum time between 1st and 2nd eye implantation is 30 days. Subjects participating in the trial will attend a total of maximum 12 study visits over a period of 330-420 days (preoperative, operative, 1-2 days, 7-14 days, 30-60 days, 120-180 days and 330-420 days postoperative visits). Subjects would have the option for unscheduled visits if required medically.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female adults ages 50 years or older on the day of screening who have clinically documented cataracts in both eyes;
- •Calculated IOL power (sphere and cylinder) is within the range of the investigational IOLs;
- •Regular corneal astigmatism (measured by a topographer);
- •Corneal astigmatism ≥0.75 D and ≤ 4.25 D (measured by an automatic keratometer) in one or both eyes;
- •Capability to understand and sign an IRB approved informed consent form and privacy authorization;
- •Clear intraocular media other than cataract;
- •Dilated pupil size large enough to visualize IOL axis markings postoperatively;
- •Best corrected visual acuity projected to be better than 0.2 logMAR after toric IOL implantation;
- •Willing and able to conform to the study requirements.
Exclusion Criteria
- •Age of patient \<50 years at the day of screening;
- •Regular corneal astigmatism \<0.75 D or \>4.25 D (measured by an automatic keratometer) in both eyes
- •Irregular astigmatism (measured by a topographer);
- •Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
- •Subjects with AMD suspicious eyes as determined by OCT examination;
- •Previous intraocular or corneal surgery;
- •Traumatic cataract;
- •History or presence of macular edema;
- •Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;
- •Clinically significant, uncontrolled glaucoma with expected negative impact on Contrast Sensitivity and/or visual acuity outcomes;
Outcomes
Primary Outcomes
Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation
Time Frame: 6 months postoperative
The primary performance endpoint is to show statistically non-inferior rotational stability outcomes on PODEYE TORIC lens compared to CER data obtained for a multifocal toric IOL (POD FT) by the same manufacturer sharing the same haptic design but based on a hydrophilic lens material. The null hypothesis is that the absolute mean IOL rotation measured on PODEYE TORIC is not larger than the absolute mean IOL rotation reported in the current CER on POD FT lens. The alternative hypothesis is that the absolute mean IOL rotation measured on PODEYE TORIC is larger than the outcomes reported in the current CER on POD FT lens. The measure is taken at 6 months postoperative visit compared to the measurement performed within 10 minutes after surgery.
Secondary Outcomes
- Best Corrected Distance Visual Acuity compared to historical Data(Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative)
- Change in cylindrical Power of the Eye(Pre-Op, 1 month postoperative, 6 months postoperative, 12 months postoperative)