Clinical trial NCT03281005: Development of Visual Function Evaluation Method
Official title: Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinitis Pigmentosa
Keywords: Retinitis pigmentosa
Visual function evaluation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2017-09-13
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retinitis pigmentosa, healthy volunteers

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.

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

Primary outcomes:
measure: Slit-lamp microscopy in Part 1A and 2
timeFrame: Up to week 8
measure: Slit-lamp microscopy in Part 1B and 3
timeFrame: Day 1
measure: Optical Coherence Tomography (OCT) test in Part 1A and 2
timeFrame: Day 1
measure: Visual acuity test with Early Treatment Diabetic Retinopathy Study (ETDRS) in Part 1A and 2
timeFrame: Up to week 8
measure: Visual acuity test with ETDRS in Part 1B
timeFrame: Day 1
measure: The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in Part 1A and 2
timeFrame: Up to week 8
measure: The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11) in Part 1A and 2
timeFrame: Up to week 8
measure: Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2
timeFrame: Up to week 8
measure: Daily living task dependent on vision (DLTV) in Part 1A and 2
timeFrame: Up to week 8
measure: Table test in Part 1A and 2
timeFrame: Up to week 8
measure: Metropsis test in Part 1A and 2
timeFrame: Up to week 8
measure: Low vision evaluator (LoVE) in Part 1A
timeFrame: Up to week 8
measure: White flash visual evoked potential (VEP) test in Part 1A and 2
timeFrame: Up to week 8
measure: White flash VEP test in Part 1B and 3
timeFrame: Day 1
measure: Color flash VEP test in Part 1A and 2
timeFrame: Up to week 8
measure: Color flash VEP test in Part 1B and 3
timeFrame: Day 1
measure: Electrically evoked response (EER) test in Part 1A and 2
timeFrame: Up to week 8
measure: EER test in Part 1B and 3
timeFrame: Day 1
measure: White flash electroretinography test in Part 1A, 1B, 2 and 3
timeFrame: Day 1
measure: Pupillary function test in Part 2
timeFrame: Up to week 8
measure: Pupillary function test in Part 1B and 3
timeFrame: Day 1
measure: Full field stimulus threshold testing (FST) in Part 2
timeFrame: Up to week 8
measure: FST in Part 1B
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Meguro-ku
country: Japan
facility: Site JP00001
state: Tokyo
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: