NCT04985097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
Last Updated

August 6, 2021

Status Verified

July 1, 2021

Enrollment Period

2.8 years

First QC Date

July 26, 2021

Last Update Submit

July 31, 2021

Conditions

Visual Disturbances and BlindnessVisual Acuity Reduced Transiently

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

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

Control group

SHAM COMPARATOR

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

Interventions

Implantation of trifocal diffractive intraocular lensesPROCEDURE

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

Control groupExperimental group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 an 90 years
  • Patients implanted with trifocal diffractive intraocular lenses
  • Availability and motivation to perform the visual training assigned

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, University of Valladolid

Valladolid, 47005, Spain

Location

Related Publications (1)

  • Pinero DP, Maldonado-Lopez MJ, Molina-Martin A, Garcia-Sanchez N, Ramon ML, Rincon JL, Holgueras A, Arenillas JF, Planchuelo-Gomez A, Leal-Vega L, Coco-Martin MB. Randomised placebo-controlled clinical trial evaluating the impact of a new visual rehabilitation program on neuroadaptation in patients implanted with trifocal intraocular lenses. Int Ophthalmol. 2023 Nov;43(11):4035-4053. doi: 10.1007/s10792-023-02809-9. Epub 2023 Jul 18.

    PMID: 37464228DERIVED

MeSH Terms

Conditions

Blindness

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental group vs control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 2, 2021

Study Start

September 1, 2018

Primary Completion

June 30, 2021

Study Completion

July 20, 2021

Last Updated

August 6, 2021

Record last verified: 2021-07

Locations

ES(1)