AmblyopiaNEIVATECHNCT04819386
NEIVATECH Virtual Reality-based System for Amblyopia
A study testing Active vision therapy sessions with the NEIVATECH Virtual Reality-based system in people with Amblyopia, run by Increase-Tech at 2 sites in Spain.
Trial summary
The NEIVATECH system has been designed to provide binocular vision training to 7-15 year old amblyopic children by discriminating Gabor patches presented with different contrast to each eye as a perceptual learning task. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Active vision therapy sessions with the NEIVATECH Virtual Reality-based system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jul 2022to 30 Sep 2024
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 7 and 15 years.
- VA in the amblyopic eye < 0.1 logMAR units.
- Interocular difference in VA ≥ 1 logMAR line.
- Interocular difference in espherical equivalent ≥ 1 D.
- Interpupillary distance (IPD) between 60.7 and 73.5 mm.
- Use of best refractive correction for at least 2 months prior to inclusion.
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- Lack of response or therapeutic adherence to conventional occlusion therapy.
- Willingness to attend all the active vision therapy sessions and/or visits of the study.
- No history of previous treatment for amblyopia other than optimal refractive correction for at least 2 months prior to inclusion.
Who cannot join
- Active eye disease.
- Previous ocular surgery.
- BCVA in the amblyopic eye of ≥ 0.70 logMAR.
- Presence of cognitive impairment or neurological or psychiatric disorders.
- Presence of irregular cornea due to astigmatism or ectatic corneal disease.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Vithas Medimar International Hospital
Alicante, 3016
University Clinical Hospital of Valladolid
Valladolid, Valladolid, 47003
About this study
Official title: Prospective Pilot Study of the NEIVATECH Virtual Reality-based System to Improve Visual Function in Children with Amblyopia
The NEIVATECH system has been designed to provide binocular vision training to 7-15 year old amblyopic children by discriminating Gabor patches presented with different contrast to each eye as a perceptual learning task.
Read the detailed description
Due to the global impact of amblyopia, there is a medical and social need, and at the same time, a clear market niche, for the design and development of new therapies that can improve recurrence rates and non-compliance with conventional treatments. In this sense, the aim of this single-arm, multicentre, prospective pilot study is to examine the safety, acceptability and clinical efficacy of a novel Virtual Reality-based system designed to provide binocular vision training to 7-15 year old amblyopic children complementing the concepts of perceptual learning and dichoptic training with a gamification approach.
- Conditions
- Amblyopia
- Being tested
- Active vision therapy sessions with the NEIVATECH Virtual Reality-based system
- Keywords
- Amblyopic children, Perceptual learning, Dichoptic training, Virtual reality, Gamification
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active vision therapy sessions with the NEIVATECH Virtual Reality-based systemOther
The active visual therapy sessions with the NEIVATECH Virtual Reality-based system will be 18 in total, will have an average duration of half an hour and will be distributed over a month as follows: 5 sessions in the first two weeks after enrollment (Monday to Friday) and 4 sessions in the next two weeks (Monday to Thursday).
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | 18 half-hour in-office active vision therapy sessions with the NEIVATECH Virtual Reality-based system Receives: Other: Active vision therapy sessions with the NEIVATECH Virtual Reality-based system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in distance best-corrected visual acuity (BCVA)
ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)
Measured: Baseline - 1 month
Secondary outcomes (2)
Change in near BCVA
ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)
Measured: Baseline - 1 month
Change in photopic contrast sensitivity function (CSF)
CSV-1000 test for spatial frequencies of 3, 6, 12 and 18 cycles/degree
Measured: Baseline - 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Jul 2022
- Primary completion1 Jul 2024
- Study completion30 Sep 2024
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Increase-Tech
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alicante, University of Valladolid, Hospital Clínico Universitario de Valladolid
- Responsible party
- Principal investigator, Juan Francisco Arenillas Lara, Increase-Tech
- Investigators
- Juan Francisco Arenillas Lara, PhD, Principal investigator, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819386
- Sponsor's protocol ID
- CASVE-NM-21-516
- Acronym
- NEIVATECH
- Status last verified
- Sep 2023
- First submitted
- 18 Mar 2021
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leal-Vega L, Coco-Martin M feminineB, Molina-Martin A, Cuadrado-Asensio R, Vallelado-Alvarez AI, Sanchez-Tocino H, Mayo-Iscar A, Hernandez-Rodriguez CJ, Arenillas Lara JF, Pinero DP. NEIVATECH pilot study: immersive virtual reality training in older amblyopic children with non-compliance or non-response to patching. Sci Rep. 2024 Nov 14;14(1):28062. doi: 10.1038/s41598-024-79565-y.
PubMed 39543340Leal Vega L, Pinero DP, Hernandez Rodriguez CJ, Molina Martin A, Morales-Quezada L, Vallelado Alvarez AI, Arenillas Lara JF, Coco Martin MB. Study protocol for a randomized controlled trial of the NEIVATECH virtual reality system to improve visual function in children with anisometropic amblyopia. BMC Ophthalmol. 2022 Jun 7;22(1):253. doi: 10.1186/s12886-022-02466-z.
PubMed 35672688
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study of the NEIVATECH Virtual Reality-based System to Improve Visual Function in Children with Amblyopia
- ClinicalTrials.gov ID
- NCT04819386
- Acronym / sponsor ID
- NEIVATECH / CASVE-NM-21-516
- Conditions
- Amblyopia
- Keywords
- Amblyopic children, Perceptual learning, Dichoptic training, Virtual reality, Gamification
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Increase-TechUniversity, hospital or other
- Collaborators
- University of Alicante, University of Valladolid, Hospital Clínico Universitario de Valladolid
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 29 Mar 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.
The NEIVATECH system has been designed to provide binocular vision training to 7-15 year old amblyopic children by discriminating Gabor patches presented with different contrast to each eye as a perceptual learning task.
Detailed description
Due to the global impact of amblyopia, there is a medical and social need, and at the same time, a clear market niche, for the design and development of new therapies that can improve recurrence rates and non-compliance with conventional treatments. In this sense, the aim of this single-arm, multicentre, prospective pilot study is to examine the safety, acceptability and clinical efficacy of a novel Virtual Reality-based system designed to provide binocular vision training to 7-15 year old amblyopic children complementing the concepts of perceptual learning and dichoptic training with a gamification approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Other: Active vision therapy sessions with the NEIVATECH Virtual Reality-based system18 half-hour in-office active vision therapy sessions with the NEIVATECH Virtual Reality-based system |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children aged between 7 and 15 years.
- VA in the amblyopic eye < 0.1 logMAR units.
- Interocular difference in VA ≥ 1 logMAR line.
- Interocular difference in espherical equivalent ≥ 1 D.
- Interpupillary distance (IPD) between 60.7 and 73.5 mm.
Key exclusion criteria (5 listed)
- Active eye disease.
- Previous ocular surgery.
- BCVA in the amblyopic eye of ≥ 0.70 logMAR.
- Presence of cognitive impairment or neurological or psychiatric disorders.
- Presence of irregular cornea due to astigmatism or ectatic corneal disease.
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 |
|---|---|---|
| Active vision therapy sessions with the NEIVATECH Virtual Reality-based systemThe active visual therapy sessions with the NEIVATECH Virtual Reality-based system will be 18 in total, will have an average duration of half an hour and will be distributed over a month as follows: 5 sessions in the first two weeks after enrollment (Monday to Friday) and 4 sessions in the next two weeks (Monday to Thursday). | Other | Active group |
Primary outcome
Change in distance best-corrected visual acuity (BCVA)
Time frame: Baseline - 1 month
ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)
2 secondary outcomes
Change in near BCVA
Time frame: Baseline - 1 month
Change in photopic contrast sensitivity function (CSF)
Time frame: Baseline - 1 month
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Derived from this study: PubMed 39543340Leal-Vega L, Coco-Martin M feminineB, Molina-Martin A, Cuadrado-Asensio R, Vallelado-Alvarez AI, Sanchez-Tocino H, Mayo-Iscar A, Hernandez-Rodriguez CJ, Arenillas Lara JF, Pinero DP. NEIVATECH pilot study: immersive virtual reality training in older amblyopic children with non-compliance or non-response to patching. Sci Rep. 2024 Nov 14;14(1):28062. doi: 10.1038/s41598-024-79565-y.
- Derived from this study: PubMed 35672688Leal Vega L, Pinero DP, Hernandez Rodriguez CJ, Molina Martin A, Morales-Quezada L, Vallelado Alvarez AI, Arenillas Lara JF, Coco Martin MB. Study protocol for a randomized controlled trial of the NEIVATECH virtual reality system to improve visual function in children with anisometropic amblyopia. BMC Ophthalmol. 2022 Jun 7;22(1):253. doi: 10.1186/s12886-022-02466-z.
- Individual participant dataSharing planned: No
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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.
Juan Francisco Arenillas Lara, PhD principal investigator
University of Valladolid
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active vision therapy sessions with the NEIVATECH Virtual Reality-based system in people with Amblyopia, run by Increase-Tech at 2 sites 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 9 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: stopped early, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
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?
Change in distance best-corrected visual acuity (BCVA) (time frame: Baseline - 1 month). 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 NCT04819386, which also lists 2 linked publications.
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 4 Oct 2024.