Home-based Visual Training in Patients Implanted With Trifocal Diffractive Intraocular Lenses (OPTicTRAIN)
Primary Purpose
Visual Disturbances and Blindness, Visual Acuity Reduced Transiently
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Implantation of trifocal diffractive intraocular lenses
Sponsored by
About this trial
This is an interventional treatment trial for Visual Disturbances and Blindness
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
Sites / Locations
- Faculty of Medicine, University of Valladolid
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Experimental group
Control group
Arm Description
Half an hour of active visual training per day for a period of 20 consecutive days with the Optictrain software
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
Outcomes
Primary Outcome Measures
Visual acuity
Monocular and binocular corrected and uncorrected visual acuity under near, intermediate and distance conditions
Contrast sensitivity
Monocular and binocular mesopic contrast sensitivity under near and distance conditions
Secondary Outcome Measures
Full Information
NCT ID
NCT04985097
First Posted
July 26, 2021
Last Updated
July 31, 2021
Sponsor
Increase-Tech
Collaborators
University of Alicante, Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA, Ministerio de Economía y Competitividad, Spain
1. Study Identification
Unique Protocol Identification Number
NCT04985097
Brief Title
Home-based Visual Training in Patients Implanted With Trifocal Diffractive Intraocular Lenses
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Increase-Tech
Collaborators
University of Alicante, Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA, Ministerio de Economía y Competitividad, Spain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Disturbances and Blindness, Visual Acuity Reduced Transiently
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental group vs control group
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Active Comparator
Arm Description
Half an hour of active visual training per day for a period of 20 consecutive days with the Optictrain software
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Implantation of trifocal diffractive intraocular lenses
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual acuity
Description
Monocular and binocular corrected and uncorrected visual acuity under near, intermediate and distance conditions
Time Frame
During the first post-operative week and after 20 days of vision training with the randomly assigned software
Title
Contrast sensitivity
Description
Monocular and binocular mesopic contrast sensitivity under near and distance conditions
Time Frame
During the first post-operative week and after 20 days of vision training with the randomly assigned software
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Faculty of Medicine, University of Valladolid
City
Valladolid
ZIP/Postal Code
47005
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Home-based Visual Training in Patients Implanted With Trifocal Diffractive Intraocular Lenses
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