Development of Visual Function Evaluation Method

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03281005

Enrollment

Registered

2017-09-13

Start date

2017-11-01

Completion date

2019-11-21

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinitis Pigmentosa

Keywords

Retinitis pigmentosa, Visual function evaluation

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Japan

Outcome results