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Evaluation of Visual Function After Bilateral Implantation of EDOF IOLs

NCT05335408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-10-19

No results posted yet for this study

Summary

Since intermediate vision is becoming increasingly important in our day-to-day tasks, a new IOL was introduced (Acunex Vario) with this objective in mind. This IOL provides excellent vision at far and intermediate distances up to 60 cm and with negligible photopic disturbances compared to conventional multifocal lenses. The Alcon AcrySof IQ Vivity IOL is designed to provide continuous vision from distance to intermediate while preserving contrast sensitivity and with a monofocal visual disturbance profile. So far, there are no published studies comparing these new IOL designs that offer an extended range of vision at far and intermediate distances.

Objective: The primary objective of this study is to compare the binocular uncorrected intermediate visual acuity (UIVA) at 66 cm under photopic conditions 3 months postoperatively, in a series of patients bilaterally implanted with the Vario IOL versus those bilaterally implanted with the Vivity IOL.

Study design: controlled double masked, randomized, prospective clinical trial Study population: patients of 18 years or older with bilateral cataracts that require cataract surgery.

Intervention: One group receives bilateral implantation with the Vario IOL and the other group receives bilateral implantation with the Vivity IOL.

Main study parameters: The main study parameter is the binocular UIVA at 66 cm under photopic conditions at 3 months postoperatively.

Hypothesis: The investigators hypothesise that bilateral implantation with the Vario IOL is non-inferior when compared to bilateral implantation with the Vivity IOL, with regards to binocular UIVA at 66 cm under photopic conditions 3 months postoperatively.

Cataract extraction in this study will proceed according to regular cataract surgery. As with any type of intraocular surgery, there is a possibility of complications due to anesthesia, drug reactions, and surgical problems. Postoperatively, there will be one extra postoperative visit, compared to standard cataract surgery follow-up. Spectacle-independency postoperatively, without photopic phenomena, is one of the major expected benefits when treating cataract (and presbyopia) with the implantation of the Vario or Vivity IOLs.

Conditions

  • Cataract Bilateral
  • Lens, Intraocular
  • Lens Implantation, Intraocular
  • Pseudophakia
  • Visual Acuity

Interventions

DEVICE

Acunex Vario intraocular lens

This is an extended depth of focus IOL, made by Teleon Surgical B.V.

DEVICE

Alcon AcrySof IQ Vivity intraocular lens

This is an extended depth of focus IOL, made by Alcon.

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Rudy Nuijts, MD, PhD · University Eye Clinic Maastricht UMC+

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-02
Primary Completion
2023-06-09
Completion
2023-06-09

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05335408 on ClinicalTrials.gov