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

Visual Acuity Reduced Transiently Clinical Trial

— OPTicTRAIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04985097
• Other study ID #: CASVENM-20-437
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: July 20, 2021

Study information

• Verified date: July 2021
• Source: Increase-Tech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 20, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Blindness
• Visual Acuity Reduced Transiently
• Visual Disturbances and Blindness

Intervention

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

Locations

Country	Name	City	State
Spain	Faculty of Medicine, University of Valladolid	Valladolid

Sponsors (4)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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