Analysis of Peripheral Vision With Two Different IOLs

NCT05639075 | Unknown

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

Brief Summary

Analyse the peripheral vision after cataract surgery with a new IOL compared to a standard IOL

Conditions

Cataract

Keywords

Cataract; Intraocular lens

Outcome Measures

Primary Outcomes (1)

• Peripheral vision

  Peripheral vision will be assessed via gait analysis and will be compared between both eyes

  24 months

Secondary Outcomes (2)

• Refraction

  24 months

• Visual acuity

  24 months

Study Arms (1)

Gait analysis

EXPERIMENTAL

A gait analysis test will be performed in each patient after cataract surgery to test peripheral vision

Other: Peripheral vision

Interventions

Peripheral vision OTHER

A gait analysis test will be performed in each patient after cataract surgery to test peripheral vision

Gait analysis

Eligibility Criteria

• Age: 21 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pseudophakic patients with an Art 40 IOL in one eye and the standard monofocal ICB00 IOL in the other eye. A larger series of patients was operated in this way at Hanusch hospital in 2021 and 2022 as the department has the strategy of implanting a new IOL that has come to market in only one eye and the standard monofocal IOL in the contralateral eye to reduce potential risks, even though the new IOL had a CE mark and was readily available on the market.
• Surgery should have been at least 1 month prior to study recruitment
• Age 21 or older
• Visual acuity \> 0,8
• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
• Able to walk without walking aids
• Written informed consent prior to commencing study measurements.

You may not qualify if:

• nystagmus or pathologies that might affect patient's fixation or physical handicaps that may decrease gait stability
• any ophthalmic comorbidity that may compromise the visual function or might interfere with the experiments (e.g., macular degeneration, corneal scars, pupil abnormalities, glaucoma)
• reduced contrast sensitivity, binocularity, and stereoscopic vision (e.g., amblyopia, strabismus)
• limitation of age-equivalent gait performance because of neurological, cardio-respiratory or musculoskeletal functional deficits
• pregnancy (pregnancy test will be performed in women of reproductive age)

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

Vienna Institute for Research in Ocular Surgery

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Oliver Findl, MD

  Vienna Institute for Research in Ocular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 6, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: December 6, 2022

Record last verified: 2022-11

Locations

AU (1)