Posterior Capsule Opafication of Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs.Clareon IOL

NCT04369482 | Unknown DMC

• 1 other identifier: Clarinex 1560/2014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an Clareon, Alcon, Fort Worth, Texas. The second eye to be operated receives the other IOL type. A complete biomicroscopic examination, visual acuity testing using autorefractometer, contrast sensitivity testing, and standardised retroillumination photography for PCO evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months) years postoperatively.

Conditions

Age Related Cataracts

Outcome Measures

Primary Outcomes (1)

• PCO score

  subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO)

  3 years

Secondary Outcomes (4)

• Visual Acuity

  3 years

• Fibrosis

  3 years

• Subjective glistening score

  3 years

• YAG capsulotomy rate

  3 years

Study Arms (2)

Alcon Clareon

ACTIVE COMPARATOR

Implantation of an intraocular lens Alcon Clareon

Device: Hoya Vivinex

Hoya Vivinex

ACTIVE COMPARATOR

Implantation of an intraocular lens Hoya Vivinex

Device: Alcon Clareon

Interventions

Alcon Clareon DEVICE

Implantation of an intraocular lens Alcon Clareon

Hoya Vivinex

Hoya Vivinex DEVICE

Implantation of an intraocular lens Hoya Vivinex

Alcon Clareon

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
• Age 50 and older
• Visual potential in both eyes of 20/30 or better as determined by investigators estimation
• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

You may not qualify if:

• Preceding intraocular surgery or ocular trauma
• Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, uveitis, retinal degenerations, etc.)
• Laser treatment
• Uncontrolled systemic or ocular disease
• Infectious disease
• Pregnancy/Nursing

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna Allgemeines Krankenhaus

Vienna, 1090, Austria

Location

Related Publications (1)

• Leydolt C, Schartmuller D, Schwarzenbacher L, Prenner V, Danzinger V, Lisy M, Abela-Formanek C, Menapace R. Posterior capsule opacification with two similar-design hydrophobic acrylic intraocular lenses: 3-year results of a randomized controlled trial. J Cataract Refract Surg. 2024 Dec 1;50(12):1242-1246. doi: 10.1097/j.jcrs.0000000000001539.

  PMID: 39137100 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: visual acuity, slitlamp examination, fibrosis, posterior capsule opacification (PCO) score and YAG capsulotomy rate.

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: January 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)