Development of Visual Function Evaluation Method (2)

Retinitis Pigmentosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626207
• Other study ID #: CLR180001
• Status: Completed
• Start date: October 4, 2018
• Est. completion date: June 26, 2019

Study information

• Verified date: July 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 26, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Locations

Country	Name	City	State
Japan	Site JP00001	Kobe	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Slit-lamp-microscopy	To assess the visual function.	Up to 3 months
Primary	Optical Coherence Tomography (OCT) test	To assess the visual function.	Day 1
Primary	Early Treatment Diabetic Retinopathy Study (ETDRS)	To assess the visual function.	Up to 3 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Table test	To assess the visual function.	Up to 3 months
Primary	Monitor test	To assess the visual function.	Up to 3 months
Primary	Pupillary function test	To assess the visual function.	Up to 3 months
Primary	Full field stimulus threshold testing (FST)	To assess the visual function.	Up to 3 months
Primary	White flash visual evoked potential (VEP) test	To assess the visual function.	Up to 3 months
Primary	Color flash VEP test	To assess the visual function.	Up to 3 months
Primary	Electrically evoked response (EER) test	To assess the visual function.	Up to 3 months
Primary	White flash Electroretinography (ERG) test	To assess the visual function.	Day 1
Primary	Multifocal ERG test	To assess the visual function.	Up to 3 months