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

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

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.

Study Overview

• Status: Completed
• Conditions: Visual Acuity Reduced Transiently; Visual Disturbances and Blindness
• Intervention / Treatment: Procedure: Implantation of trifocal diffractive intraocular lenses

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valladolid, Spain, 47005
    • Faculty of Medicine, University of Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Experimental group; Half an hour of active visual training per day for a period of 20 consecutive days with the Optictrain software	Procedure: Implantation of trifocal diffractive intraocular lenses; 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
SHAM_COMPARATOR: Control group; Half an hour of using a videogame without specific stimuli to improve visual performance (Fun Kid Racing 3.53 for Android) per day for a period of 20 consecutive days	Procedure: Implantation of trifocal diffractive intraocular lenses; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Monocular and binocular corrected and uncorrected visual acuity under near, intermediate and distance conditions	During the first post-operative week and after 20 days of vision training with the randomly assigned software
Contrast sensitivity	Monocular and binocular mesopic contrast sensitivity under near and distance conditions	During the first post-operative week and after 20 days of vision training with the randomly assigned software

Collaborators and Investigators

• Sponsor: Increase-Tech
• Collaborators: Ministerio de Economía y Competitividad, Spain; University of Alicante; Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): July 20, 2021

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (ACTUAL): August 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 31, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Blindness
• Other Study ID Numbers: CASVENM-20-437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No