Dark Focus of AccommodationNCT03358550
Night Myopia and Dark Focus of Accommodation
A study testing Accommodation Measurement in people with Dark Focus of Accommodation, run by University of Applied Sciences Jena at 1 site in Germany.
Trial summary
Shifts in accommodation at decreasing luminance levels are considered as principle cause for night myopia. Previous studies with laser optometers quantified the dark focus of accommodation up to 3 D. Read more about this study
- Who is it for?
- Ages 22 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Dark Focus of Accommodation
- What is being tested?
- Accommodation Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteGermany
- Study dates
- 2 Feb 2017to 23 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18 - 44
- visual acuity at least 0.8 (5/6)
Who cannot join
- medication with an impact on the visual system
- visual disease or disease with an impact on the visual system
- pregnancy or other hormonal variances
- drug usage
- overfatigue at the period of investigation
- mental handicap
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of an Imaginary Target on the State of Accommodation Under Scotopic Conditions
Shifts in accommodation at decreasing luminance levels are considered as principle cause for night myopia. Previous studies with laser optometers quantified the dark focus of accommodation up to 3 D. In addition to the measurement of dark focus, the aim of this study was to investigate the influence of an imaginary target at finite distances on the state of accommodation at scotopic luminance.
Read the detailed description
Accommodation was measured by using an open-field autorefractor (WAM 5500, GRAND SEIKO). Full corrected right eyes of 39 subjects aged from 18 to 40 years were investigated in this randomized, cross-sectional study. Accommodation measurements in photopic luminance were taken for 6 m of empty field and for optotype fixation at 2 m, 1 m and 0.5 m. At scotopic luminance, dark focus of accommodation was examined directly after darkening and after 10 min of dark adaptation. After adaptation, subjects had to visualize imaginary targets in the four distances while accommodation was measured.
- Conditions
- Dark Focus of Accommodation
- Being tested
- Accommodation Measurement
- Keywords
- accommodation, dark focus, night myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accommodation MeasurementDiagnostic test
Accommodation was measured for different distances and light conditions.
| Study group | Role | What they receive |
|---|---|---|
| Accommodation in scotopic luminance | Experimental | Not described Receives: Diagnostic Test: Accommodation Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shift of accommodation in scotopic luminance (Dark focus)
Accommodative shift in scotopic luminance compared to photopic luminance for empty field (dark focus of accommodation)
Measured: Baseline only
Secondary outcomes (3)
Difference of accommodation for 2 m target
Accommodative shift in scotopic luminance compared to photopic luminance for the fixation of a target in 2 m
Measured: Baseline only
Difference of accommodation for 1 m target
Accommodative shift in scotopic luminance compared to photopic luminance for the fixation of a target in 1 m
Measured: Baseline only
Difference of accommodation for 0.5 m target
Accommodative shift in scotopic luminance compared to photopic luminance for the fixation of a target in 0.5 m
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start2 Feb 2017
- Primary completion23 Mar 2017
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dark Focus of AccommodationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Hessler, University of Applied Sciences Jena
- Investigators
- Philipp Hessler, M.Sc., Principal investigator, University of Applied Sciences Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358550
- Sponsor's protocol ID
- UASJena
- Status last verified
- Nov 2017
- First submitted
- 26 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of an Imaginary Target on the State of Accommodation Under Scotopic Conditions
- ClinicalTrials.gov ID
- NCT03358550
- Acronym / sponsor ID
- UASJena
- Conditions
- Dark Focus of Accommodation
- Keywords
- accommodation, dark focus, night myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Applied Sciences JenaUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 23 Mar 2017 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shifts in accommodation at decreasing luminance levels are considered as principle cause for night myopia. Previous studies with laser optometers quantified the dark focus of accommodation up to 3 D. In addition to the measurement of dark focus, the aim of this study was to investigate the influence of an imaginary target at finite distances on the state of accommodation at scotopic luminance.
Detailed description
Accommodation was measured by using an open-field autorefractor (WAM 5500, GRAND SEIKO). Full corrected right eyes of 39 subjects aged from 18 to 40 years were investigated in this randomized, cross-sectional study. Accommodation measurements in photopic luminance were taken for 6 m of empty field and for optotype fixation at 2 m, 1 m and 0.5 m. At scotopic luminance, dark focus of accommodation was examined directly after darkening and after 10 min of dark adaptation. After adaptation, subjects had to visualize imaginary targets in the four distances while accommodation was measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accommodation in scotopic luminance | Experimental | Diagnostic Test: Accommodation Measurement |
Who may qualify
- Ages
- 22 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 18 - 44
- visual acuity at least 0.8 (5/6)
Key exclusion criteria (6 listed)
- medication with an impact on the visual system
- visual disease or disease with an impact on the visual system
- pregnancy or other hormonal variances
- drug usage
- overfatigue at the period of investigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accommodation MeasurementAccommodation was measured for different distances and light conditions. | Diagnostic test | Accommodation in scotopic luminance |
Primary outcome
Shift of accommodation in scotopic luminance (Dark focus)
Time frame: Baseline only
Accommodative shift in scotopic luminance compared to photopic luminance for empty field (dark focus of accommodation)
3 secondary outcomes
Difference of accommodation for 2 m target
Time frame: Baseline only
Difference of accommodation for 1 m target
Time frame: Baseline only
Difference of accommodation for 0.5 m target
Time frame: Baseline only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Hessler, M.Sc. principal investigator
University of Applied Sciences Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accommodation Measurement in people with Dark Focus of Accommodation, run by University of Applied Sciences Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shift of accommodation in scotopic luminance (Dark focus) (time frame: Baseline only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.