Visual Acuity Reduced Transiently, Visual Disturbances and Blindness
Conditions
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.
Interventions
PROCEDUREImplantation 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
Sponsors
University of Alicante
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Ministerio de Economía y Competitividad, Spain
Increase-Tech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Experimental group vs control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Spain
Outcome results
None listed