Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05684250 |
| Other study ID # |
IRBNET.ORG 1933308 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 19, 2022 |
| Est. completion date |
May 31, 2024 |
Study information
| Verified date |
January 2023 |
| Source |
State University of New York College of Optometry |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will examine the accommodative behavior in young adults wearing multifocal soft
contact lenses. undergoing myopia control treatments. Subjects will undergo auditory
biofeedback training while wearing the multifocal contact lenses to improve the
accommodative. This pilot study is divided into three separate experiments and aims to
assess:
1. the time course of the effect of biofeedback training in young adults wearing MFCLs --
the time course group
2. whether repeated biofeedback training increases the efficacy in young adults wearing
MFCLs -- the repetition group
3. whether a longer training duration, given repeatedly, increases the efficacy in young
adults wearing MFCLs -- the longer duration group
The results of this study will be used to design a larger clinical trial to investigate
whether increasing accommodative responses through the multifocal contact lenses increases
multifocal lenses' treatment effect on myopia management in children.
Description:
The public health systems worldwide might soon face an increase in highly myopic patients and
with this a rising number of cases with severe eye diseases. By 2050, about five billion
people are expected to be myopic and one billion might suffer from a myopia of more than -5
D. According to the World Health Organization, myopia is one of the top factors leading to
avoidable blindness. For decades, researchers have been investigating the etiology of this
refractive error as well as methods to prevent its progression in children myopic. Among the
currently available treatments to slow myopia progression, optical interventions were shown
to be a promising and feasible non-invasive approach. Hyperopic retinal defocus is known to
induce ocular axial elongation and may be a factor in the progression of myopia. Positive
defocus has been shown to reduce axial elongation and contact lenses with bi- or multifocal
power profiles that add positive power to the central distance have been used to reduce
myopia progression in children. Clinical trial outcomes show progression to be reduced, on
average, by 38% on average, but with variable results. This variability may be related to the
ways patients accommodate through the lenses. An earlier study found that children wearing
multifocal lenses may under-accommodate at near, which could reduce the efficacy of the
lenses.
Biofeedback training has been used to change accommodation. Earlier studies attempted to
reduce accommodation based on the hypothesis that functional myopia results from a spasm of
the ciliary muscle. In contrast, a recent study with young adult myopes successfully applied
auditory biofeedback training to *increase* accommodation accuracy and reduce the
accommodative lag in individuals by 0.3 D or more at different dioptric distances and while
myopic subjects wore multifocal contact lenses. If accommodation was increased by means of
auditory biofeedback training in myopic children wearing multifocal soft contact lenses, the
treatment efficacy of the lenses might be improved.
The purpose of this pilot study is to investigate whether the frequency and duration of
auditory biofeedback training affect their efficacy in increasing accommodative responses
through the multifocal lenses.
• STUDY POPULATION
Thirty subjects will be randomized to one of the three study groups:
1. The time course group: The time course of the effect of biofeedback training (one
episode) on accommodation in young adults wearing MFCLs will be measured weekly
2. The repetition group: The effect of repeated biofeedback training (one episode per week
for 3 weeks) on accommodation through the MFCLs will be measured weekly
3. The longer duration group: The effect of repeated biofeedback training with longer
duration (one episode per week for 3 weeks) on accommodation through the MFCLs will be
measured weekly
INCLUSION CRITERIA
- Best corrected monocular Snellen visual acuity (VA) ≧ 20/25
- Age 18 to 30 years
- Refractive error spherical equivalent between -0.75 D and -10 D
- Astigmatism ≤ 0.75 D
- Age-appropriate amplitude of accommodation
- No suspected or confirmed eye disease (anamnesis)
- No accommodative or binocular function abnormalities
- Agreement to participate in the study (informed consent of subjects)
EXCLUSION CRITERIA
- Persons who are incapable of giving consent
- Refractive error spherical equivalent < -10 D and > -0.75 D
- Astigmatism > 0.75 D
- Abnormal binocular functions
- Medication affecting accommodative response or causing dry eye
