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| Name | Class |
|---|---|
| IGA OPTIC EG | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Night Spectacle Correction | Experimental | Refraction for this glasses was obtained at low luminance. |
|
| Spectacle Correction for photopic light conditions | Active Comparator | Refraction for this glasses was obtained at high luminance level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectacle/Glasses | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline only |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Degle, Prof. | University of Applied Sciences Jena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Degle Optometry | Augsburg | Bavaria | Germany | |||
| Hessler Optometry |
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| ID | Title | Description |
|---|---|---|
| FG000 | Night Spectacle Correction - Photopic Spectacle Correction | This arm has tested first the mesopic spectacle correction for 2 weeks and after this time the ("standard") photopic spectacle correction for two weeks Cross Over Design! |
| FG001 | Photopic Spectacle Correction - Night Spectacle Correction | This arm has tested first the standard photopic spectacle correction for two weeks and after this time the mesopic spectacle correction for two weeks Cross Over Design! |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects were included in Baseline and all investigations were obtained at these 100 subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | D | Baseline only |
|
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study time
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Night Spectacle Correction | Refraction for this glasses was obtained at low luminance. Spectacle/Glasses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philipp Hessler | University of Applied Sciences Jena | +4916097089677 | philipp@hessler.de |
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| ID | Term |
|---|---|
| C536122 | Night blindness, congenital stationary |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| 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) | 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) | 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) | 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) | Test Period (4 weeks) |
| Klingenberg am Main |
| Bavaria |
| 63911 |
| Germany |
| University of Applied Sciences | Jena | Thuringia | 07745 | Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Aberrometry Spherical Equivalent (SE) small pupil OD | OD = right eye. Spherical Equivalent was calculated with data of an aberrometer (VISIONIX VX120 family). Spherical Equivalent is calculated by (sph + 0.5*cyl). | Mean | Standard Deviation | D |
|
| Aberrometry SE at small pupil OS | SE = Spherical Equivalent. OS = left eye. Spherical Equivalent was calculated with data of an aberrometer (VISIONIX VX120 family). Spherical Equivalent is calculated by (sph + 0.5*cyl). | Mean | Standard Deviation | D |
|
| Subjective photopic Refraction SE OD | SE = Spherical Equivalent OD = Right Eye Subjective Refraction measured in a photopic luminance level (comparable to an eye examination for new glasses). Spherical Equivalent was calculated with data of subjective refraction. Spherical Equivalent is calculated by (sph + 0.5*cyl). | Mean | Standard Deviation | D |
|
| Subjective photopic Refraction SE OS | SE = Spherical Equivalent OS = Left Eye Subjective Refraction measured in a photopic luminance level (comparable to an eye examination for new glasses). Subjective Refraction measured in a photopic luminance level. Spherical Equivalent was calculated with data of subjective refraction. Spherical Equivalent is calculated by (sph + 0.5*cyl). | Mean | Standard Deviation | D |
|
| Photopic Visual Acuity OD | Best Corrected Visual Acuity in a photopic luminance. OD = Right Eye 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32, -0.1 to 20/16, etc. | Median | Full Range | logMAR Visual Acuity |
|
| Photopic Visual Acuity OS | Best Corrected Visual Acuity in a photopic luminance OS = Left Eye. 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32, -0.1 to 20/16, etc | Median | Full Range | logMAR Visual Acuity |
|
| Binocular photopic Visual Acuity | Best Corrected Visual Acuity in a photopic luminance, binocular. 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32, -0.1 to 20/16, etc. | Median | Full Range | logMAR Visual Acuity |
|
| Mesopic Visual Acuity with photopic refraction OD | Visual Acuity measured in a mesopic luminance, wearing refraction values measured in photopic luminance OD = Right Eye. 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32, -0.1 to 20/16, etc. | Median | Full Range | logMAR Visual Acuity |
|
| Mesopic Visual Acuity with photopic refraction OS | Visual Acuity measured in a mesopic luminance, wearing refraction values measured in photopic luminance OS = Left Eye. 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32, -0.1 to 20/16, etc. | Median | Full Range | logMAR Visual Acuity |
|
| Mesopic Visual Acuity with photopic refraction Binocular | Visual Acuity measured in a mesopic luminance, wearing refraction values measured in photopic luminance Binocular. 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32, -0.1 to 20/16, etc. | Median | Full Range | logMAR Visual Acuity |
|
| Subjective Mesopic Refraction SE OD | Mesopic Refraction measured in mesopic luminance (comparable to an eye examination for new glasses in a darkened room). OD = Right Eye SE = Spherical Equivalent | Mean | Standard Deviation | D |
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| Subjective Mesopic Refraction SE OS | Mesopic Refraction measured in mesopic luminance (comparable to an eye examination for new glasses in a darkened room). OS = Right Eye SE = Spherical Equivalent | Mean | Standard Deviation | D |
|
| Mesopic Visual Acuity with Mesopic Refraction OD | Best corrected visual acuity after refraction in mesopic luminance OD = Right Eye. 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32, -0.1 to 20/16, etc. | Median | Full Range | logMAR Visual Acuity |
|
| Mesopic Visual Acuity with Mesopic Refraction OS | Best corrected visual acuity after refraction in mesopic luminance OS = Left Eye. 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32, -0.1 to 20/16, etc. | Median | Full Range | logMAR Visual Acuity |
|
| Mesopic Visual Acuity with Mesopic Refraction Binocular | Best corrected visual acuity after refraction in mesopic luminance Binocular. 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32, -0.1 to 20/16, etc. | Median | Full Range | logMAR Visual Acuity |
|
| Spherical Aberration OD | Measured by Aberrometry OD = Right Eye | Mean | Standard Deviation | µm |
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| Spherical Aberration OS | Measured by Aberrometry OS = Left Eye | Mean | Standard Deviation | µm |
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| Max. pupil size aberrometry OD | measured by aberrometry OD = Right Eye | Mean | Standard Deviation | mm |
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| Max. pupil size aberrometry OS | measured by aberrometry OS = Left Eye | Mean | Standard Deviation | mm |
|
| Aberrometry Spherical Equivalent (SE) large pupil OD | OD = Right Eye. Spherical Equivalent was calculated with data of an aberrometer (VISIONIX VX120 family). Spherical Equivalent is calculated by (sph + 0.5*cyl). SE value of max. pupil size. | Mean | Standard Deviation | D |
|
| Aberrometry Spherical Equivalent (SE) large pupil OS | OS = Left Eye. Spherical Equivalent was calculated with data of an aberrometer (VISIONIX VX120 family). Spherical Equivalent is calculated by (sph + 0.5*cyl). SE value of max. pupil size. | Mean | Standard Deviation | D |
|
| Pupil size in photopic light conditions OD | Measured by Infra Red Camera in photopic conditions OD = Right Eye | Mean | Standard Deviation | mm |
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| Pupil size in photopic light conditions OS | Measured by Infra Red Camera in photooic conditions. OS = Left Eye | Mean | Standard Deviation | mm |
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| Pupil size in mesopic light conditions OD | Measured by Infra Red Camera in mesopic conditions. OD = Right Eye | Mean | Standard Deviation | mm |
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| Pupil size in mesopic light conditions OS | Measured by Infra Red Camera in mesopic conditions OS = Left Eye | Mean | Standard Deviation | mm |
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| J0 Aberrometry OD small pupil | J0 = Astigmatism component OD = Right Eye | Mean | Standard Deviation | D |
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| J0 Aberrometry OS small pupil | J0 = Astigmatism component OS = Left Eye | Mean | Standard Deviation | D |
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| J45 Aberrometry OD small pupil | J45 = Astigmatism component OD = Right Eye | Mean | Standard Deviation | D |
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| J45 Aberrometry OS small pupil | J45 = Astigmatism component OS = Left Eye | Mean | Standard Deviation | D |
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| J0 Aberrometry OD large pupil | J0 = Astigmatism component OD = Right Eye | Mean | Standard Deviation | D |
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| J0 Aberrometry OS large pupil | J0 = Astigmatism component OS = Left Eye | Mean | Standard Deviation | D |
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| J45 Aberrometry OD large pupil | J45 = Astigmatism component OD = Right Eye | Mean | Standard Deviation | D |
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| J45 Aberrometry OS large pupil | J45 = Astigmatism component OS = Left Eye | Mean | Standard Deviation | D |
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| J0 Subjective Photopic Refraction OD | J0 = Astigmatism component Calculated after performing cross-cylinder method OD = Right Eye | Mean | Standard Deviation | D |
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| J0 Subjective Photopic Refraction OS | J0 = Astigmatism component Calculated after performing cross-cylinder method OS = Left Eye | Mean | Standard Deviation | D |
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| J45 Subjective Photopic Refraction OD | J45 = Astigmatism component Calculated after performing cross-cylinder method OD = Right Eye | Mean | Standard Deviation | D |
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| J45 Subjective Photopic Refraction OS | J45 = Astigmatism component Calculated after performing cross-cylinder method OS = Left Eye | Mean | Standard Deviation | D |
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| J0 Subjective Mesopic Refraction OD | J0 = Astigmatism component Calculated after performing cross-cylinder method in a darkened room OD = Right Eye | Mean | Standard Deviation | D |
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| J0 Subjective Mesopic Refraction OS | J0 = Astigmatism component Calculated after performing cross-cylinder method in a darkened room OS = Left Eye | Mean | Standard Deviation | D |
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| J45 Subjective Mesopic Refraction OD | J45 = Astigmatism component Calculated after performing cross-cylinder method in a darkened room OD = Right Eye | Mean | Standard Deviation | D |
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| J45 Subjective Mesopic Refraction OS | J45 = Astigmatism component Calculated after performing cross-cylinder method in a darkened room OS = Left Eye | Mean | Standard Deviation | D |
|
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| Secondary | 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. | Posted | Median | Full Range | logMAR visual acuity | Baseline only |
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| Secondary | 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) | Posted | Mean | Standard Deviation | scores on a scale (0 to 100) | Test Period (4 weeks) |
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| Secondary | 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) | Posted | Mean | Standard Deviation | evaluation points (0 to 100) | Test Period (4 weeks) |
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| Secondary | 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) | Posted | Mean | Standard Deviation | scores on a scale (0 to 100) | Test Period (4 weeks) |
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| Secondary | 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) | Posted | Mean | Standard Deviation | scores on a scale (0 to 100) | Test Period (4 weeks) |
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| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Spectacle Correction for Photopic Light Conditions | Refraction for this glasses was obtained at high luminance level. Spectacle/Glasses | 0 | 100 | 0 | 100 | 0 | 100 |
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