NCT04985097: OPTicTRAIN

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

Completed NA Last updated 6 August 2021

What this trial tests

NA trial testing Implantation of trifocal diffractive intraocular lenses in Visual Disturbances and Blindness in 60 participants. Completed in 20 July 2021.

Timeline

1 September 2018

Primary endpoint
30 June 2021

20 July 2021

Quick facts

Lead sponsor	Increase-Tech
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	1 September 2018
Primary completion	30 June 2021
Estimated completion	20 July 2021
Sites	1 location across Spain

Drugs / interventions tested

• Implantation of trifocal diffractive intraocular lenses

Conditions studied

• Visual Disturbances and Blindness — all drugs for Visual Disturbances and Blindness →
• Visual Acuity Reduced Transiently — all drugs for Visual Acuity Reduced Transiently →

Sponsor

Increase-Tech

Who can join

Adults 18 to 90, any sex, with Visual Disturbances and Blindness or Visual Acuity Reduced Transiently. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Preliminary Evaluation of the Clinical Benefit of a Novel Visual Rehabilitation Program in Patients Implanted with Trifocal Diffractive Intraocular Lenses: A Blinded Randomized Placebo-Controlled Clinical Trial.
   Piñero DP, Molina-Martin A, Ramón ML, Rincón JL, et al · · 2021 · cited 4× · PMID 34573202 · DOI 10.3390/brainsci11091181
2. Randomised placebo-controlled clinical trial evaluating the impact of a new visual rehabilitation program on neuroadaptation in patients implanted with trifocal intraocular lenses.
   Piñero DP, Maldonado-López MJ, Molina-Martin A, García-Sánchez N, et al · · 2023 · cited 3× · PMID 37464228 · DOI 10.1007/s10792-023-02809-9