Myopia-Night BlindnessNCT02965534
Evaluation of a Night Spectacle Correction Concerning an Improvement of Mesopic Vision Quality
A study testing Spectacle/Glasses in people with Myopia-Night Blindness, run by University of Applied Sciences Jena at 3 sites in Germany.
Trial summary
Reduced quality of vision and glare in twilight or night are frequently mentioned complaints within the optometric examination. A reason for these problems could be a myopic refractive shift in dark light conditions, commonly known as night myopia or twilight myopia. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia-Night Blindness
- What is being tested?
- Spectacle/Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesGermany
- Study dates
- Oct 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Visual Acuity at least 0.8 (5/6)
- Binocular Vision
Who cannot join
- refraction more than sph +/- 6 D and cyl 2 D
- Difference between habitual correction and actual refraction more than 0.5 D
- Medication with an influence on visual system
- Disease or eye disease with an effect on the visual system
- pregnancy or other hormonal variances
- influence of drugs
- mental handicap
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Degle Optometry
Augsburg, Bavaria
University of Applied Sciences
Jena, Thuringia, 07745
Hessler Optometry
Klingenberg am Main, Bavaria, 63911
About this study
Reduced quality of vision and glare in twilight or night are frequently mentioned complaints within the optometric examination. A reason for these problems could be a myopic refractive shift in dark light conditions, commonly known as night myopia or twilight myopia.
The aim of this study was to investigate whether quality of vision in twilight or night could be improved by a spectacle correction optimized for mesopic light conditions. Moreover, objective refraction in large pupils measured by aberrometry was compared to subjective mesopic refraction.
Read the detailed description
After obtaining informed consent, aberrometry was performed in a darkened room (0.1 lux). Subjective photopic refraction and visual acuity were measured before light was turned off and mesopic refraction was obtained after a dark adaptation period of five minutes. Finally, frames and lenses were fitted by a centration system. Lens grinding was executed centralized by a grinding workshop. In the course of this study, subjects were randomly assigned to wear two glasses double-masked in turn. One with photopic subjective refraction data and another with mesopic subjective refraction data. Both were worn for 14 ± 2 days each.
Follow Up 1:
After two weeks, participants were asked for their subjective experiences with the first correction by a visual analogue scale questionnaire. After the evaluation, glasses were changed.
Follow Up 2:
Two weeks later, subjective experiences were evaluated again. After visual analogue scale questionnaire, subjects were asked to compare the two glasses concerning quality of mesopic vision and subjective safety level during night driving.
- Conditions
- Myopia-Night Blindness
- Being tested
- Spectacle/Glasses
- Keywords
- night vision, mesopic visual acuity, aberrometry, mesopic spectacle correction, night myopia
- Medical subject headings
- Night blindness, congenital stationary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectacle/GlassesDevice
| Study group | Role | What they receive |
|---|---|---|
| Night Spectacle Correction | Experimental | Refraction for this glasses was obtained at low luminance. Receives: Device: Spectacle/Glasses |
| Spectacle Correction for photopic light conditions | Active comparator | Refraction for this glasses was obtained at high luminance level. Receives: Device: Spectacle/Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Night Myopia
Value of refractive shift (SE) when changing luminance from a photopic to a mesopic level.
At Baseline, participants were not separated into arms as the Randomization Process was carried out at a later time point after participants picked up study glasses. Therefore, data are presented for All Participants in one Arm/Group.
Measured: Baseline only
Secondary outcomes (5)
Mesopic Visual Acuity Improvement
Difference of visual acuity (monocular and binocular) in a darkened room (0.1 lux) after a dark adaption period of 5 min. with photopic spectacle correction ("classic" refraction obtained in photopic light conditions) compared to mesopic spectacle correction (correction of night myopia)
Scale: logMAR visual acuity, using Landolt C optotypes.
At Baseline, participants were not separated into arms as the Randomization Process was carried out at a later time point after participants picked up study glasses. Therefore, data are presented for All Participants in one Arm/Group.
Measured: Baseline only
Subjective Vision Comfort in Dark Light Conditions
Evaluation of subjective perceived vision comfort with the study and control glasses.
Both glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.
Question:
How would you evaluate vision comfort with the tested glasses in dark light conditions? Answer: visual analogue scale slider from 0 (insufficient) to 100 (very good)
Measured: Test Period (4 weeks)
Subjective Vision Sharpness in Dark Light Conditions
Evaluation of subjective perceived vision sharpness with the study and control glasses.
Both glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.
Question:
How would you evaluate vision sharpness with the tested glasses in dark light conditions? Answer: visual analogue scale slider from 0 (insufficient) to 100 (very good)
Measured: Test Period (4 weeks)
Subjective Glare Sensitivity in Dark Light Conditions
Evaluation of subjective perceived glare sensitivity with the study and control glasses.
Both glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.
Question:
How would you evaluate glare sensitivity with the tested glasses in dark light conditions? Answer: visual analogue scale slider from 0 (no glare) to 100 (strong glare)
Measured: Test Period (4 weeks)
Subjective Driving Safety in Dark Light Conditions
Evaluation of subjective perceived driving safety sense with the study and control glasses.
Both glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.
Question:
How would you evaluate driving safety sense when driving in twilight or night with the tested glasses? Answer: visual analogue scale slider from 0 (not safe) to 100 (very safe)
Measured: Test Period (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startOct 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myopia-Night BlindnessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences Jena
- Sponsor type
- University, hospital or other
- Collaborators
- IGA OPTIC EG
- Responsible party
- Principal investigator, Stephan Degle, University of Applied Sciences Jena
- Investigators
- Stephan Degle, Prof., Principal investigator, University of Applied Sciences Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965534
- Sponsor's protocol ID
- IGAMYO
- Status last verified
- Oct 2018
- First submitted
- 14 Nov 2016
- Last updated
- 28 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Night Spectacle Correction Concerning an Improvement of Mesopic Vision Quality
- ClinicalTrials.gov ID
- NCT02965534
- Acronym / sponsor ID
- IGAMYO
- Conditions
- Myopia-Night Blindness
- Keywords
- night vision, mesopic visual acuity, aberrometry, mesopic spectacle correction, night myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Applied Sciences JenaUniversity, hospital or other
- Collaborators
- IGA OPTIC EG
- Study start
- Oct 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Posted 28 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reduced quality of vision and glare in twilight or night are frequently mentioned complaints within the optometric examination. A reason for these problems could be a myopic refractive shift in dark light conditions, commonly known as night myopia or twilight myopia.
The aim of this study was to investigate whether quality of vision in twilight or night could be improved by a spectacle correction optimized for mesopic light conditions. Moreover, objective refraction in large pupils measured by aberrometry was compared to subjective mesopic refraction.
Detailed description
After obtaining informed consent, aberrometry was performed in a darkened room (0.1 lux). Subjective photopic refraction and visual acuity were measured before light was turned off and mesopic refraction was obtained after a dark adaptation period of five minutes. Finally, frames and lenses were fitted by a centration system. Lens grinding was executed centralized by a grinding workshop. In the course of this study, subjects were randomly assigned to wear two glasses double-masked in turn. One with photopic subjective refraction data and another with mesopic subjective refraction data. Both were worn for 14 ± 2 days each.
Follow Up 1:
After two weeks, participants were asked for their subjective experiences with the first correction by a visual analogue scale questionnaire. After the evaluation, glasses were changed.
Follow Up 2:
Two weeks later, subjective experiences were evaluated again. After visual analogue scale questionnaire, subjects were asked to compare the two glasses concerning quality of mesopic vision and subjective safety level during night driving.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Night Spectacle Correction | Experimental | Device: Spectacle/GlassesRefraction for this glasses was obtained at low luminance. |
| Spectacle Correction for photopic light conditions | Active comparator | Device: Spectacle/GlassesRefraction for this glasses was obtained at high luminance level. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Visual Acuity at least 0.8 (5/6)
- Binocular Vision
Key exclusion criteria (7 listed)
- refraction more than sph +/- 6 D and cyl 2 D
- Difference between habitual correction and actual refraction more than 0.5 D
- Medication with an influence on visual system
- Disease or eye disease with an effect on the visual system
- pregnancy or other hormonal variances
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 |
|---|---|---|
| Spectacle/Glasses | Device | Night Spectacle Correction, Spectacle Correction for photopic light conditions |
Primary outcome
Night Myopia
Time frame: Baseline only
Value of refractive shift (SE) when changing luminance from a photopic to a mesopic level. At Baseline, participants were not separated into arms as the Randomization Process was carried out at a later time point after participants picked up study glasses. Therefore, data are presented for All Participants in one Arm/Group.
5 secondary outcomes
Mesopic Visual Acuity Improvement
Time frame: Baseline only
Subjective Vision Comfort in Dark Light Conditions
Time frame: Test Period (4 weeks)
Subjective Vision Sharpness in Dark Light Conditions
Time frame: Test Period (4 weeks)
Subjective Glare Sensitivity in Dark Light Conditions
Time frame: Test Period (4 weeks)
Subjective Driving Safety in Dark Light Conditions
Time frame: Test Period (4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Stephan Degle, Prof. principal investigator
University of Applied Sciences Jena
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectacle/Glasses in people with Myopia-Night Blindness, run by University of Applied Sciences Jena at 3 sites 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 7 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 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 28 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Night Myopia (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 28 Feb 2019.