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

Study Overview
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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.

Official Title
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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

Conditions
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Visual Disturbances and Blindness, Visual Acuity Reduced Transiently

Intervention / Treatment
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* Procedure: Implantation of trifocal diffractive intraocular lenses


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental group vs control group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental group<br>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<br>* 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<br>|
| Sham Comparator: Control group<br>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<br>* 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<br>|

What is the study measuring?
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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 |