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Clinical Trials/NCT04985097
NCT04985097
Completed
Not Applicable

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

Increase-Tech1 site in 1 country60 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Visual Disturbances and Blindness
Sponsor
Increase-Tech
Enrollment
60
Locations
1
Primary Endpoint
Visual acuity
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
July 20, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Increase-Tech
Responsible Party
Sponsor

Eligibility Criteria

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

Time Frame: 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

Time Frame: 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

Study Sites (1)

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