NCT04985097

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Increase-Tech · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Visual Disturbances and Blindness
• Visual Acuity Reduced Transiently

Interventions

Type	Name	Description
PROCEDURE	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

Timeline

• Start date: 2018-09-01
• Primary completion: 2021-06-30
• Completion: 2021-07-20
• First posted: 2021-08-02
• Last updated: 2021-08-06

Locations

1 site across 1 country: Spain