Effects of Stulln and Accommodative Training

Effects of Stulln Eye Drops and Accommodative Training on Accommodative Responses and Visual Fatigue

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.

Study Overview

• Status: Withdrawn
• Conditions: Accommodation Disorder; Visual Fatigue
• Intervention / Treatment: Drug: Stulln Eyedrops; Drug: Thera Tears

Detailed 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.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Forest Grove, Oregon, United States, 97116
      • Vision Performance Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be between 18 and 45 years of age.
• Have normal/corrected-to-normal monocular acuity of better than 20/25 for both eyes.
• Have normal contrast sensitivity.
• Be a native English speakers or possess college-level English reading proficiency.
• Have a current optical prescription (obtained less than 2 years ago).
• Have accommodative dysfunctions, including reduced accommodative amplitude, range, facility and endurance.

Exclusion Criteria:

• Have no prismatic correction.
• No clinically significant ocular pathology (e.g., cataract, keratoconus, dry eye, diabetic retinopathy, or age-related macular degeneration) that would limit the effectiveness of vision training.
• Have no binocular dysfunction, including amblyopia, strabismus, and other binocular diseases that would impede accommodative training.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stulln Eyedrops; 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; 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.; Other Names: Accommodative training
Sham Comparator: Theta Tears; 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; The eyedrops will be used in the identical manner as Stulln eyedrops.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline, 4th, and 8th week

Collaborators and Investigators

• Sponsor: Pacific University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2021
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Fatigue; Asthenopia; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: Stulln-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No