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

• Sponsor: Increase-Tech (Other)
• Overall Status: Completed
• CT.gov ID: NCT04985097
• Collaborator: University of Alicante (Other), Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA (Other), Ministerio de Economía y Competitividad, Spain (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 34.6
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Visual Disturbances and Blindness; Visual Acuity Reduced Transiently	Procedure: Implantation of trifocal diffractive intraocular lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Experimental group vs control groupExperimental group vs control group
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Sep 1, 2018
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Jul 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Experimental group 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; 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
Sham Comparator: 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	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

Outcome Measures

Primary Outcome Measures

1. Visual acuity [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

2. Contrast sensitivity [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, University of Valladolid	Valladolid		Spain	47005

Sponsors and Collaborators

• Increase-Tech
• University of Alicante
• Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
• Ministerio de Economía y Competitividad, Spain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Increase-Tech
• ClinicalTrials.gov Identifier: NCT04985097
• Other Study ID Numbers: CASVENM-20-437
• First Posted: Aug 2, 2021
• Last Update Posted: Aug 6, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Blindness

Study Results

No Results Posted as of Aug 6, 2021