Development of Visual Function Evaluation Method (2)

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

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

Study Overview

• Status: Completed
• Conditions: Retinitis Pigmentosa

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Japan
  • Hyogo
    • Kobe, Hyogo, Japan
      • Site JP00001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Retinitis pigmentosa

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Retinitis pigmentosa; Retinitis pigmentosa patients with severe visual impairment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 4, 2018
• Primary Completion (ACTUAL): June 26, 2019
• Study Completion (ACTUAL): June 26, 2019

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (ACTUAL): August 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Retinitis pigmentosa; Visual function evaluation
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis; Retinitis Pigmentosa
• Other Study ID Numbers: CLR180001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual patient level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Information for Astellas."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No