PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Spain

NCT ID: NCT04866719

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2024-04-04

Brief Summary

This is a multicentric, 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. PHY2103)

Detailed Description

This is a multicentric, 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. 75 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.

Conditions

Cataract; Lens Opacities; Astigmatism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PODEYE TORIC IOL Implantation experimental

Mono- or bilateral implantation of toric intraocular lenses PODEYE TORIC

Group Type: EXPERIMENTAL

IOL implantation experimental

Intervention Type: 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).

Interventions

IOL implantation experimental

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).

Intervention Type: DEVICE

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;
• Clinically significant, uncontrolled glaucoma with expected negative impact on Contrast Sensitivity and/or visual acuity outcomes;
• Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;
• Ocular hypertension, suspicious glaucoma or glaucoma;
• 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);
• Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF).

• zonular instability;
• need for iris manipulation;
• capsular fibrosis or other opacity; and
• inability to fixate IOL in desired position. In such cases, the subject shall be followed until the condition has stabilized.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

targomedGmbH

INDUSTRY

Sponsor Role: collaborator

Beaver-Visitec International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco Poyales Galan, MD

Role: PRINCIPAL_INVESTIGATOR

Miranza IOA Madrid

Locations

Oftalvist Alicante

Alicante, , Spain

Miranza IMO Barcelona

Barcelona, , Spain

Oftalvist Juan Bravo

Madrid, , Spain

Miranza Virgen de Luján

Seville, , Spain

Oftalvist Valencia

Valencia, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 20505205 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26274516 (View on PubMed)

Other Identifiers

PHY2103

Identifier Type: -

Identifier Source: org_study_id