ClinicalTrials.gg
WithdrawnNCT05107791Updated May 21, 2024

Effects of Stulln and Accommodative Training

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 Withdrawn at 1 site in United States.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

Why this study was withdrawn
unable to attend the drug for study
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Accommodation Disorder
  • Visual Fatigue

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03

In context

Asthenopia

67 studies on the registry are indexed under Asthenopia; 10 are open to participants now.

Browse Asthenopia studies →

Lead sponsor

Pacific University is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Have no prismatic correction.
  • No 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugStulln 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.

    Also known as: Accommodative training

  • DrugThera Tears

    The eyedrops will be used in the identical manner as Stulln eyedrops.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

1 site
  • Vision Performance Institute
    Forest Grove, Oregon 97116, United States
08

References and documents

Individual participant data

Plan to share: No — IPD will not be shared.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2021 to primary completion in Aug 2021, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2018
First posted
Nov 4, 2021
StartActual
Mar 15, 2021
Primary completionActual
Aug 31, 2021
CompletionActual
Aug 31, 2021
Last update
May 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05107791
Lead sponsor
Pacific University
Responsible party
Shun-nan Yang (Director of Vision Performance Institute, Pacific University) — Principal investigator
First posted
Nov 4, 2021
Start date
Mar 15, 2021
Primary completion
Aug 31, 2021
Completion
Aug 31, 2021
Last update
May 21, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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