Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05107791 |
| Other study ID # |
Stulln-1 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2021 |
| Est. completion date |
August 31, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Pacific University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The present study tests the hypothesis that Stulln eyedrops improve accommodative functions
by improving the short term facility of ciliary muscles that can be transferred into
long-term adaptation. To test this, the investigators propose to conduct a prospective
randomized control trials where participants with accommodative dysfunctions are randomly
assigned to four groups: control, Stulln only and Stulln plus vision training. The
investigators' theory predicts that the efficacy of Stulln will be augmented by vision
training.
Description:
Accommodation is the process of adjusting focal distance to achieve a clear retinal vision by
altering the shape of human crystalline lens in the eye. Accommodative responses are composed
of two parts, phasic and tonic. The adequate phasic accommodation is needed to form a clear
retinal image of near stimuli. The proper tonic accommodation is needed to maintain clear
retinal vision after the initial phasic response. The phasic and tonic accommodative
responses are mediated by the sympathetic and parasympathetic systems. Accommodative accuracy
and endurance is achieved by modifying the neuromuscular connection through repetitive
learning and adaptation.
Vision training has been shown effective to increase accommodative amplitude and endurance.
Its efficacy is achieved by gradually increasing the difficulty of tasks that require
patients to attentively process visual cues to adapt their accommodative responses. Its end
goal is to induce effective and permanent adaptations to the visual environment. The process
of vision training has been theorized as a bioengineering model in which the neuromuscular
signal is altered through visuomotor feedback. The increase in accommodative accuracy is
thought to reflect the gain of accommodative responses and the increase of accommodative
endurance is the result of maintained tonic neural output.
Empirical studies have shown the Digitalisglycosides (DGS) can enhance muscular contraction
and Esculin improves micro vascular circulation. Stulln eyedrops include these active
ingredients and have been approved to treat visual discomfort and retinal macular diseases in
Europe and China. It also has a very good safety record, without any report of adverse
effects to human body for the millions of users each year. The efficacy of Stulln in treating
visual discomfort might have resulted from the improved microcirculation of blood and wastes,
leading to better ciliary functions. Indeed, empirical studies have shown Stulln application
can improve accommodative amplitude, facility and endurance. However, Stullen itself might
not produce long-term changes in neuromuscular innervation, as its ingredients can be removed
from the human body within an day.
The present study tests the hypothesis that Stulln eyedrops improve accommodative functions
by improving the short term accommodative facility and endurance. To test this, the
investigators propose to conduct a prospective randomized control trials where participants
with accommodative dysfunctions are randomly assigned to three groups: control, Stulln only
and Stulln plus vision training. The investigators' theory predicts that the efficacy of
Stulln will be augmented by vision training.
