PMCF Study on Comparison of EDOF Lenses (Switzerland)

NCT05235139 | Completed

• 1 other identifier: PHY2130
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of a premium monofocal intraocular lens (PhysIOL ISOPURE 1.2.3.) with clinical data obtained in a control group implanted with an EDOF IOL (Alcon Acrysof IQ Vivity).

Conditions

Cataract; Lens Opacities

Keywords

Intraocular Lens; EDOF; hydrophobic; IOL

Outcome Measures

Primary Outcomes (1)

• monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.

  Non inferiority of ISOPURE 1.2.3. outcomes compared to the Acrysof IQ Vivity outcomes in terms of monocular Best Corrected Distance Visual Acuity (CDVA) by means of statistical significance. A significance level of 0.05 or lower (p \< 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018.

  6 months (120-180 days) postoperative

Secondary Outcomes (1)

• Safety (Rates of Adverse Events)

  1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative

Other Outcomes (31)

• Intraocular pressure (IOP) measurement

  Preoperative, 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative

• Keratometry

  Preoperative

• IOL power

  Operative (day of surgery)

Study Arms (2)

IOL implantation experimental

EXPERIMENTAL

Experimental arm: Premium monofocal intraocular lens.

Device: IOL implantation experimental (ISOPURE 1.2.3.)

IOL implantation active comparator

ACTIVE COMPARATOR

Comparator arm: EDOF intraocular lens.

Device: IOL implantation active comparator (Acrysof Vivity)

Interventions

IOL implantation experimental (ISOPURE 1.2.3.) DEVICE

Implantation of premium monofocal IOL ISOPURE 1.2.3.

IOL implantation experimental

IOL implantation active comparator (Acrysof Vivity) DEVICE

Implantation of EDOF IOL Acrysof Vivity

IOL implantation active comparator

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cataractous eyes with no comorbidity;
• Calculated IOL power is within the range of the study IOLs;
• Male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes;
• Regular total corneal astigmatism ≤1.0 D (measured by topography method)
• Clear intraocular media other than cataract;
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
• Expected postoperative Best Corrected Distance Visual Acuity (CDVA) ≤ 0.2 logMAR;
• Signed informed consent.

You may not qualify if:

• Age of patient \< 50 years;
• Regular total corneal astigmatism \>1.0 dioptres (measured by topography method)
• Irregular astigmatism;
• Difficulty for cooperation (distance from their home, general health conditions);
• Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
• Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema or macula pucker;
• Previous intraocular or corneal surgery or intravitreal injection;
• Traumatic cataract;
• History or presence of macular edema;
• Glaucoma with visual field defects;
• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
• Amblyopia with monocular preoperative CDVA of \>0.1 logMAR;
• Cornea guttata;
• Keratoconus;
• Chronic uveitis;

Sponsors & Collaborators

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

Study Sites (1)

Eye center Vista Alpina

Visp, 3930, Switzerland

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

• Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22.

  PMID: 28341605 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Kristof Vandekerkchove, MD

  Eye center Vista Alpina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind masking; Patient will not be informed which IOL model was implanted until end of the study. Outcomes assessors will not be informed which IOL model was implanted until end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 11, 2022
• Study Start: March 9, 2022
• Primary Completion: August 22, 2023
• Study Completion: August 22, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)