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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-07-20

Brief Summary

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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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Detailed Description

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Conditions

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Visual Disturbances and Blindness Visual Acuity Reduced Transiently

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental group vs control group

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Experimental group

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

Group Type ACTIVE_COMPARATOR

Implantation of trifocal diffractive intraocular lenses

Intervention Type 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

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

Group Type SHAM_COMPARATOR

Implantation of trifocal diffractive intraocular lenses

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No