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Effects of Stulln and Accommodative Training

Primary Purpose

Accommodation Disorder, Visual Fatigue

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stulln Eyedrops
Thera Tears
Sponsored by
Pacific University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Accommodation Disorder

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Vision Performance Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Stulln Eyedrops

Theta Tears

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
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.
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.
Change in Visual Fatigue
Change in the score measured from CISS questionnaire between the baseline, 4-week, and 8-week assessment.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2018
Last Updated
October 25, 2021
Sponsor
Pacific University
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1. Study Identification

Unique Protocol Identification Number
NCT05107791
Brief Title
Effects of Stulln and Accommodative Training
Official Title
Effects of Stulln Eye Drops and Accommodative Training on Accommodative Responses and Visual Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
unable to attend the drug for study
Study Start Date
March 15, 2021 (Anticipated)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pacific University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accommodation Disorder, Visual Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stulln Eyedrops
Arm Type
Experimental
Arm Description
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).
Arm Title
Theta Tears
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Stulln Eyedrops
Other Intervention Name(s)
Accommodative training
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Thera Tears
Intervention Description
The eyedrops will be used in the identical manner as Stulln eyedrops.
Primary Outcome Measure Information:
Title
Change in Accommodative amplitude
Description
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
Title
Chang in Accommodative Facility
Description
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
Title
Change in Accommodative Endurance
Description
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
Title
Change in Visual Fatigue
Description
Change in the score measured from CISS questionnaire between the baseline, 4-week, and 8-week assessment.
Time Frame
Baseline, 4th, and 8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Vision Performance Institute
City
Forest Grove
State/Province
Oregon
ZIP/Postal Code
97116
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared.

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Effects of Stulln and Accommodative Training

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