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

Increase-Tech60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Visual Disturbances and Blindness Visual Acuity Reduced Transiently

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Visual acuity

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

Time frame: 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