PMCF Study on Monofocal Toric IOL (PODEYE TORIC)

NCT04744467 | Completed

• 1 other identifier: PHY2101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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)

Conditions

Cataract; Lens Opacities; Astigmatism

Keywords

Intraocular Lens; Monofocal; Toric Lens

Outcome Measures

Primary Outcomes (1)

• Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation

  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.

  6 months postoperative

Secondary Outcomes (2)

• 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

Other Outcomes (35)

• Intraocular pressure (IOP) measurement

  Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

• Keratometry

  Pre-Op, 1 month postoperative, 6 months postoperative

• Biometry

  Pre-Op

Study Arms (1)

PODEYE TORIC IOL Implantation experimental

EXPERIMENTAL

Mono- or bilateral implantation of toric intraocular lenses PODEYE TORIC

Device: IOL implantation experimental

Interventions

IOL implantation experimental DEVICE

Mono- or bilateral implantation of toric intraocular lenses PODEYE TORIC. 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 receive an implantation with the monofocal parent lens PODEYE (PhysIOL sa/nv, Liège, Belgium).

PODEYE TORIC IOL Implantation experimental

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study;
• Concurrent or previous (within 30 days) participation in another drug or device investigation;
• Clinically significant dry eye as determined by the investigator' s judgement;
• Ocular surface disease (clinical symptoms or keratitis);
• Patients showing contraindications as listed in the current Instructions for use (IFU);

Sponsors & Collaborators

• Beaver-Visitec International, Inc.: lead
• targomedGmbH: collaborator

Study Sites (1)

Gemini Eye Clinic

Zlín, 760 01, Czechia

Location

Related Publications (2)

• McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.

  PMID: 20505205 BACKGROUND

• Kretz FT, Breyer D, Klabe K, Hagen P, Kaymak H, Koss MJ, Gerl M, Mueller M, Gerl RH, Auffarth GU. Clinical Outcomes After Implantation of a Trifocal Toric Intraocular Lens. J Refract Surg. 2015 Aug;31(8):504-10. doi: 10.3928/1081597X-20150622-01.

  PMID: 26274516 BACKGROUND

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Pavel Stodulka, MD

  Gemini Eye Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 9, 2021
• Study Start: May 5, 2021
• Primary Completion: June 8, 2023
• Study Completion: December 19, 2023
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)