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

Not Applicable

Completed

• Conditions: Visual Disturbances and Blindness; Visual Acuity Reduced Transiently
• Interventions: Procedure: Implantation of trifocal diffractive intraocular lenses

• Registration Number: NCT04985097
• Lead Sponsor: Increase-Tech

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2021-06-30
• Status Verified: 2021-07
• Study Completion: 2021-07-20
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Last Update Submitted: 2021-07-31
• Study First Posted: 2021-08-02
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Implantation of trifocal diffractive intraocular lenses	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
Experimental group	Implantation of trifocal diffractive intraocular lenses	Half an hour of active visual training per day for a period of 20 consecutive days with the Optictrain software

Primary Outcome Measures

Name	Time	Method
Visual acuity	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
Contrast sensitivity	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

Trial Locations

Locations (1)

Faculty of Medicine, University of Valladolid; 🇪🇸 Valladolid, Spain