Development of Visual Function Evaluation Method

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient

Detailed Description
-----------------
This study is a prospective observational study which consists of 4 Parts; Part 1A, 1B, 2 and 3. Part 1A has been conducted on 6 subjects diagnosed with retinitis pigmentosa. Additional examination will be performed using alternative devices imported outside Japan on subjects who completed Part 1A and re-consented (Part 1B). Based on the interim result of Part 1A, Part 2 will be conducted on another 6 subjects with retinitis pigmentosa with improved methodology and the devices used in Part 1B. Part 3 will be conducted in 6 healthy volunteers to obtain comparative data using devices used in Part 1B.

Official Title
-----------------
Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss

Conditions
-----------------
Retinitis Pigmentosa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for patients with retinitis pigmentosa: Age: ≥ 20 years Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent Inclusion Criteria for healthy Volunteers: Age: ≥ 35 and ≤ 75 years Subjects with corrected visual acuity ≥ 1.0 with both eyes and without severe refractive error nor abnormal findings in slit-lamp microscopy, OCT, fundoscopy and pupillary function test at screening Exclusion Criteria: Subjects who have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months Subjects who have history of surgery, past history, and complications (cardiac/ hepatic/ renal/ respiratory/ hematological diseases, optic nerve diseases causing marked loss of visual field, and uveitis etc.) that potentially affect evaluation and safety of the study Pregnant women Subjects who are judged that continuation of the study is difficult during the study period Subjects who are employed by the company sponsoring this study, an organization or institution related to this study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retinitis pigmentosa in Part 1A<br>Retinitis pigmentosa patients with severe visual impairment | |
| Retinitis pigmentosa in Part 1B<br>Retinitis pigmentosa patients with severe visual impairment | |
| Retinitis pigmentosa in Part 2<br>Retinitis pigmentosa patients with severe visual impairment | |
| Healthy volunteers in Part 3<br>Healthy volunteers | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit-lamp microscopy in Part 1A and 2 | To assess the visual function | Up to week 8 | 
| Slit-lamp microscopy in Part 1B and 3 | To assess the visual function | Day 1 | 
| Optical Coherence Tomography (OCT) test in Part 1A and 2 | To assess the visual function | Day 1 | 
| Visual acuity test with Early Treatment Diabetic Retinopathy Study (ETDRS) in Part 1A and 2 | To assess the visual function | Up to week 8 | 
| Visual acuity test with ETDRS in Part 1B | To assess the visual function | Day 1 | 
| The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in Part 1A and 2 | To assess the visual function and the quality of life (QOL) | Up to week 8 | 
| The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11) in Part 1A and 2 | To assess the visual function and QOL | Up to week 8 | 
| Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2 | To assess the psychological adjustment | Up to week 8 | 
| Daily living task dependent on vision (DLTV) in Part 1A and 2 | To assess QOL | Up to week 8 | 
| Table test in Part 1A and 2 | To assess the visual function | Up to week 8 | 
| Metropsis test in Part 1A and 2 | To assess the visual function | Up to week 8 | 
| Low vision evaluator (LoVE) in Part 1A | To assess the visual function | Up to week 8 | 
| White flash visual evoked potential (VEP) test in Part 1A and 2 | To assess the visual function | Up to week 8 | 
| White flash VEP test in Part 1B and 3 | To assess the visual function | Day 1 | 
| Color flash VEP test in Part 1A and 2 | To assess the visual function | Up to week 8 | 
| Color flash VEP test in Part 1B and 3 | To assess the visual function | Day 1 | 
| Electrically evoked response (EER) test in Part 1A and 2 | To assess the visual function | Up to week 8 | 
| EER test in Part 1B and 3 | To assess the visual function | Day 1 | 
| White flash electroretinography test in Part 1A, 1B, 2 and 3 | To assess the visual function | Day 1 | 
| Pupillary function test in Part 2 | To assess the visual function | Up to week 8 | 
| Pupillary function test in Part 1B and 3 | To assess the visual function | Day 1 | 
| Full field stimulus threshold testing (FST) in Part 2 | To assess the visual function | Up to week 8 | 
| FST in Part 1B | To assess the visual function | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinitis pigmentosa, Visual function evaluation