Last reviewed · How we verify
NCT04807361
Assessment of Accommodation Behavior in Children Under Myopia Control Treatment (Pilot Study)
trial testing Auditory biofeedback traing in Accomodation in 44 participants. Completed in 12 December 2022.
12 December 2022
Quick facts
| Lead sponsor | State University of New York College of Optometry |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 44 |
| Start date | 1 December 2020 |
| Primary completion | 12 December 2022 |
| Estimated completion | 12 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Auditory biofeedback traing
Conditions studied
- Accomodation — all drugs for Accomodation →
- Biofeedback Training — all drugs for Biofeedback Training →
- Myopia — all drugs for Myopia →
Sponsor
State University of New York College of Optometry
Who can join
Adults 8 to 15, any sex, with Accomodation or Biofeedback Training. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will examine the accommodative behavior in children undergoing myopia control treatments. A subset of children showing reduced accommodation, known to occur in while wearing multifocal soft contact lenses (MFCL) from previous studies, will undergo auditory biofeedback training to improve the accommodative response and possibly improve treatment efficacy. The results of this study will be used to design a larger clinical trial. Aim 1 - The accommodation response in myopic children being treated with MFCL for six months or longer, will be determined. The accommodative response data will be collected while the patients are wearing the MFCL and will be compared to the baseline control response when the subjects wear single vision soft contact lenses (SVCL). Additional comparisons will include accommodative measures in untreated myopic children wearing spectacle corrections (unttreated controls), children being treated with ortho-keratology contact lenses, and children treated with low-dose atropine (0.01%, considered not to affect accommodation). How these additional myopia treatments affect the accommodation response has yet to be determined. Aim 2 - Children treated with MFCL who show reduced accommodative responses will undergo a brief period of auditory biofeedback accommodative training to determine whether the response in children can be improved and how long it can be sustained. Improving the accommodative response in these patients may improve the treatment efficacy by increasing the effect of the positive power addition built into the lenses.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04807361
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other State University of New York College of Optometry trials
Trials by the same sponsor.
- NCT05714449 — OCT Eccentric Fixation and Amblyopia in Children · NA · recruiting
- NCT05684224 — Assessing Dynamic Reading Behaviors Using Eye-Tracking Tobii Glasses · unknown
- NCT05505292 — Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers · Phase 4 · completed
- NCT05684250 — Effect of Biofeedback Training on Accommodation During Multifocal Lens Wear in Young Adults · NA · unknown
- NCT04448535 — Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04807361 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by State University of New York College of Optometry
- Last refreshed: 4 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04807361.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing