A Phase 1/2 interventional study of Stulln Eyedrops and Thera Tears in Accommodation Disorder and Visual Fatigue, sponsored by Pacific University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Pacific University · Phase 1/2, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
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Clinically significant
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Augentropfen Stulln Mono Eye Drops (Stulln eyedrops) will be provided to participants in individual single-use vials. Participants will apply the drops to the two eyes 3 times a day, six days a week before sustained eye use (except Sunday).
Drug: Stulln Eyedrops
Thera Tears (Sodium Carboxymethylcellulose 0.25%) will be provided to participants in individual single-use vials. Participants will apply the drops to the two eyes 3 times a day, six days a week before sustained eye use (except Sunday).
Drug: Thera Tears
Stulln eyedrops will be applied to the anterior surface of cornea 3 times a day, 6 days a week. Half of participants (46) also receive accommodative training during the second stage (month) of the study while the rest maintains the Stulln eyedrops intervention.
Also known as: Accommodative training
The eyedrops will be used in the identical manner as Stulln eyedrops.
Change in Accommodative amplitude
The change in the diopter value of the closest distance at which the visual image con be kept clear between the baseline, 4-week, and 8-week assessments.
Time frame: Baseline, 4th and 8th week
Chang in Accommodative Facility
Change in the frequency of clearing the image with +/- 2D flipper in a minute between the baseline, 4-week, and 8-week assessments.
Time frame: Baseline, 4th and 8th week
Change in Accommodative Endurance
The change in the difference in the frequency of clearing the image in two consecutive minutes measured at the baseline, 4th week, and 8th week.
Time frame: Baseline, 4th, and 8th week
Change in Visual Fatigue
Change in the score measured from CISS questionnaire between the baseline, 4-week, and 8-week assessment.
Time frame: Baseline, 4th, and 8th week
Plan to share: No — IPD will not be shared.
No publications or documents are linked to this record.
Ran from Mar 2021 to primary completion in Aug 2021, 5 months.
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This study is withdrawn, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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