H53.5 H25 H35
Conditions
Interventions
Group 1: Control subjects with normal vision
Ophthalmologic examination (OCT
BCVA
Medical/ophthalmological
history
AVIQ-24 Questionnaire
Slit lamp examination incl.
IOP
Lens classification) to ensure inclusion and exclusion
criteria
Computerized VA-threshold assessment with up-and down-staircase
procedure using Landolt-C-rings on a high luminance/high contrast monitor in
1 m distance
measurements of VA-threshold at in total 6 levels of contrast of
Landolt C-ring on the monitor and 6 levels of luminance provided by highpower
LED screens (1.2 x 1.2 m) immediately behind the monitor,
Part 1: (3 months): Pilot scale in participants
with normal vision (n = 46) and ACHM patients with impaired vision (n
= 24), definition of test-retest variability
Part 3: (8 months): Normative values, collected partly in parallel to part 2 (total n = 138, i.e. 68 in addition to 46 participants with normal vision and 24 patients with ACHM already measured in par
follow up visit 12 months after baseline of 24 ACHM patients already measured in part 1.
Group 2: Achromatopsia (ACHM)
Ophthalmologic examination (OCT
measurements of VA-threshold at in total 6 levels of contrast of
Landolt C-ring on the monitor and 6 levels of luminance provided by highpower
LED screens (
Sponsors
Universitätsklinikum Tübingen, Department für Augenheilkunde
Eligibility
Sex/Gender
All
Age
6 Years to 58 Years
Inclusion criteria
Inclusion criteria: Control subjects: BCVA monocular ? 0.8 decimal (Snellen 6/7.5); age 6 - 58 years; no history of abnormal glare sensitivity, no suspected or confirmed eye disease in history and/or standard eye examination; agreement to participate in the study. Patients: • Group 1: Achromatopsia (ACHM) Age 6 - 58 years, VA ? 0.1 decimal, LOCSIII Cataract grading < 2 or pseudophacic • Group 2: Cone dystrophy (CD) Age 18 - 58 years, VA ? 0.1 decimal, LOCSIII Cataract grading < 2 or pseudophacic • Group 3: Cataract (Cat) Age 18 - 58 years, VA ? 0.2 decimal, history of increased subjective glare sensitivity (Note: as prevalence of cataract with glare sensitivity below age 58 is very rare, age limit may need to be expanded to age 80 years for cataract patients and comparison of Visual Acuity Space is then made not with values of controls but only with the average standard BCVA value of these individuals) All groups: Agreement to participate in the study.
Exclusion criteria
Exclusion criteria: Control subjects: Subjects who are incapable of giving consent. Subjects with conspicuous OCT results. Impaired vision group (Patients): Patients who are incapable of giving consent; having any eye disease other than achromatopsia, cone dystrophy, or cataract. Patients with conspicuous OCT results other than to be expected. All groups: Any (additional) eye disease or systemic disease or condition having influence upon the measurement according to the judgement of the investigator and study physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Definition of the amount of change of visual acuity in 18 regions (A-R) and six zones of contrast and ambient luminance (A-D; E-H; I-L; M-P; Q, R) typical for activities of daily living (Visual Acuity Space (VAS); see Fig.1) and determination of normative values, sub-stratified by Age-correlated normative data (three age ranges) and/or gender. Furthermore, definition of test-retest variability in healthy subjects and ACHM patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison with clinical standard VA assessed under EDTRS lighting conditions (80-100 cd/m2, corresponding to test point 4 of the visual acuity space in Fig.1) 2. Proof of concept in three different patient groups, that glare sensitive participants can be differentiated from non- or little glare sensitive participants by defining the degree of visual acuity loss in certain VAS-regions as assessed numerically by the VA-CAL test 3. Definition of the minimally required difference VA considered as clinically relevant 4. Development of an analysis plan documenting statistical hypotheses for different VA-CAL scores to summarize optimally differences between VAS values of each participant and the three patient groups in relation to age/gender related VAS values of Healthy Group and evaluation of the scores. Several scores will be explored: (a) 3-D Volume between the VA 2-D spaces of ACHM, CD and Cat patients in relation to the VA 2-D spaces of the Healthy Group, normalized at standard ETDRS-VA (Point 4 in Fig. 1); (b) Total Sum of VA-delta values between Healthy Group and patient groups in 18 VAS Regions and in the 16 VA test points, in relation to ETDRS standard VA (Test point 4) 5. In participants with photoaversion (ACHM, CD, CAT): Number of test points and regions with clinically relevant differences in relation to healthy group 6. Correlation of VA-CAL results to subjective photoaversion in daily living (PSQ-scale 1-10) and other study measures (e.g. PROs) | — |
Countries
Germany
Contacts
Public ContactTorsten Straßer
Universitätsklinikum Tübingen, Department für Augenheilkunde
Outcome results
None listed