Visual Disturbances and BlindnessOPTicTRAINNCT04985097
Home-based Visual Training in Patients Implanted With Trifocal Diffractive Intraocular Lenses
A study testing Implantation of trifocal diffractive intraocular lenses in people with Visual Disturbances and Blindness and Visual Acuity Reduced Transiently, run by Increase-Tech at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Visual Disturbances and Blindness, Visual Acuity Reduced Transiently
- What is being tested?
- Implantation of trifocal diffractive intraocular lenses
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2018to 20 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 an 90 years
- Patients implanted with trifocal diffractive intraocular lenses
- Availability and motivation to perform the visual training assigned
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Implantation of trifocal diffractive intraocular lenses
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of trifocal diffractive intraocular lensesProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Half an hour of active visual training per day for a period of 20 consecutive days with the Optictrain software Receives: 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 Receives: Procedure: Implantation of trifocal diffractive intraocular lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Monocular and binocular corrected and uncorrected visual acuity under near, intermediate and distance conditions
Measured: 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
Measured: During the first post-operative week and after 20 days of vision training with the randomly assigned software
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Sep 2018
- Primary completion30 Jun 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visual Disturbances and BlindnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group vs control group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Increase-Tech
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alicante, Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA, Ministerio de Economía y Competitividad, Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985097
- Sponsor's protocol ID
- CASVENM-20-437
- Acronym
- OPTicTRAIN
- Status last verified
- Jul 2021
- First submitted
- 26 Jul 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37464228
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04985097
- Acronym / sponsor ID
- OPTicTRAIN / CASVENM-20-437
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Increase-TechUniversity, hospital or other
- Collaborators
- University of Alicante, Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA, Ministerio de Economía y Competitividad, Spain
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Experimental group vs control group
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Procedure: Implantation of trifocal diffractive intraocular lensesHalf an hour of active visual training per day for a period of 20 consecutive days with the Optictrain software |
| Control group | Sham comparator | Procedure: Implantation of trifocal diffractive intraocular lensesHalf 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 an 90 years
- Patients implanted with trifocal diffractive intraocular lenses
- Availability and motivation to perform the visual training assigned
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of trifocal diffractive intraocular lensesPostsurgical 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 | Procedure or surgery | Control group, Experimental group |
Primary outcome
Visual acuity
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Derived from this study: PubMed 37464228Pinero 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of trifocal diffractive intraocular lenses in people with Visual Disturbances and Blindness and Visual Acuity Reduced Transiently, run by Increase-Tech at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: During the first post-operative week and after 20 days of vision training with the randomly assigned software). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04985097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.