Development of Visual Function Evaluation Method (2)

NCT03626207 | Completed

• 1 other identifier: CLR180001
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient.

Conditions

Retinitis Pigmentosa

Keywords

Retinitis pigmentosa; Visual function evaluation

Outcome Measures

Primary Outcomes (16)

• Slit-lamp-microscopy

  To assess the visual function.

  Up to 3 months

• Optical Coherence Tomography (OCT) test

  To assess the visual function.

  Day 1

• Early Treatment Diabetic Retinopathy Study (ETDRS)

  To assess the visual function.

  Up to 3 months

• The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25)

  NEI VFQ 25 is a questionnaire intended to measure visual function and quality of life. It has 25 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (worst) to 100 (best).

  Up to 3 months

• The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11)

  NEI VFQ 11 is a questionnaire intended to measure visual function and quality of life. It has 11 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (worst) to 100 (best).

  Up to 3 months

• Nottingham Adjustment Scale Japanese Version (NAS-J)

  NAS-J is the Japanese version of NAS which measures psychological adjustment to the visual impairment, and to assess its validity and reliability. The NAS is composed of 7 psychological subscales including anxiety-depression, self-esteem, attitude to disability, locus of control, acceptance of disability, self-efficacy and attributional style. The original response of each item are coded as per the NAS-J scoring system ranging from 0 (lowest psychological adjustment) to 100 (highest psychological adjustment).

  Up to 3 months

• Daily living task dependent on vision (DLTV) questionnaire

  DLTV is a quality of life questionnaire composed of 22 items to obtain estimates of self-reported ability to perform vision-related tasks in persons with visual impairment. Participants rate items on a four-point scale, with "Can't see to do" (score, 1), "A lot of difficulty" (score, 2), "A little difficulty" (score, 3), and"No difficulty" (score, 4). The original response of each item are coded as per the DLTV scoring system ranging from 0 (worst) to 100 (best).

  Up to 3 months

• Table test

  To assess the visual function.

  Up to 3 months

• Monitor test

  To assess the visual function.

  Up to 3 months

• Pupillary function test

  To assess the visual function.

  Up to 3 months

• Full field stimulus threshold testing (FST)

  To assess the visual function.

  Up to 3 months

• White flash visual evoked potential (VEP) test

  To assess the visual function.

  Up to 3 months

• Color flash VEP test

  To assess the visual function.

  Up to 3 months

• Electrically evoked response (EER) test

  To assess the visual function.

  Up to 3 months

• White flash Electroretinography (ERG) test

  To assess the visual function.

  Day 1

• Multifocal ERG test

  To assess the visual function.

  Up to 3 months

Study Arms (1)

Retinitis pigmentosa

Retinitis pigmentosa patients with severe visual impairment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retinitis pigmentosa

You may qualify if:

• Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent and at screening

You may not qualify if:

• Subjects should not have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months
• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Site JP00001

Kobe, Hyōgo, Japan

Location

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 10, 2018
• Study Start: October 4, 2018
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: October 21, 2024

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)