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

Increase-Tech

Status: Completed

Conditions: Visual Disturbances and Blindness; Visual Acuity Reduced Transiently

Treatments: Procedure: Implantation of trifocal diffractive intraocular lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT04985097

CASVENM-20-437

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Experimental group

Active Comparator group

Description:

Half an hour of active visual training per day for a period of 20 consecutive days with the Optictrain software

Treatment:

Procedure: Implantation of trifocal diffractive intraocular lenses

Control group

Sham Comparator group

Description:

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

Treatment:

Procedure: Implantation of trifocal diffractive intraocular lenses