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Completed

NCT Number: NCT04985097

Home-based Visual Training in Patients Implanted With Trifocal Diffractive Intraocular Lenses

This multicentre randomised controlled trial aimed to reduce the visual discomfort that patients implanted with trifocal diffractive intraocular lenses may experience after surgery. To this end, a visual training software (Optictrain) was developed in which Gabor patches were presented to the patient on a hand-held electronic device. Patients who met all inclusion criteria and consented to participate underwent half an hour of visual training per day for a period of 20 consecutive days remotely on a colourimetrically characterised Samsung Galaxy Tab A device on which the Optictrain software (n=30) or a placebo software (n=30), respectively, was pre-installed. Corrected and uncorrected near, intermediate and distance visual acuity (VA) and mesopic near and distance contrast sensitivity (CS) were measured monocularly and binocularly at two visits: during the first postoperative week (V0) and after 20 days of visual training with the assigned software (V1). The statistical analysis of the results obtained in the study has not yet been carried out.

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Key information

Conditions

Visual Disturbances and Blindness Blindness Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders Visual Acuity Reduced Transiently

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, University of Valladolid

Valladolid, 47005, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 an 90 years
  • Patients implanted with trifocal diffractive intraocular lenses
  • Availability and motivation to perform the visual training assigned

Exclusion criteria

  • Age under 18 or over 90 years
  • Presence of irregular cornea, illiteracy or cognitive impairment
  • History of eye surgery or presence of any active ocular disease
  • Intraoperative complications leading to significant visual sequelae
  • Patients implanted with monofocal, extended depth of focus or refractive multifocal IOLs

Treatment and study plan

Implantation of trifocal diffractive intraocular lenses

Procedure

Postsurgical monocular and binocular assessment of corrected and uncorrected near, intermediate and distance visual acuity and near and distance mesopic contrast sensitivity before and after the assigned vision training

Primary outcomes

  1. Visual acuity

    Time frame: During the first post-operative week and after 20 days of vision training with the randomly assigned software

    Monocular and binocular corrected and uncorrected visual acuity under near, intermediate and distance conditions

  2. Contrast sensitivity

    Time frame: During the first post-operative week and after 20 days of vision training with the randomly assigned software

    Monocular and binocular mesopic contrast sensitivity under near and distance conditions

Sponsors and collaborators

Lead sponsor

Increase-Tech

Other

Collaborators

  • Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
  • Ministerio de Economía y Competitividad, Spain
  • University of Alicante

Registry information

Official study title

Preliminary Evaluation of the Clinical Benefit of a Novel Visual Rehabilitation System in Patients Implanted With Trifocal Diffractive Intraocular Lenses: A Blinded Randomized Placebo-controlled Clinical Trial

Acronym: OPTicTRAIN

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 2, 2021
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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