Development of Visual Function Evaluation Method

October 18, 2024 updated by: Astellas Pharma Inc

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Meguro-ku, Tokyo, Japan
        • Site JP00001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Retinitis pigmentosa, healthy volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Retinitis pigmentosa in Part 1A
Retinitis pigmentosa patients with severe visual impairment
Retinitis pigmentosa in Part 1B
Retinitis pigmentosa patients with severe visual impairment
Retinitis pigmentosa in Part 2
Retinitis pigmentosa patients with severe visual impairment
Healthy volunteers in Part 3
Healthy volunteers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Slit-lamp microscopy in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function
Up to week 8
Slit-lamp microscopy in Part 1B and 3
Time Frame: Day 1
To assess the visual function
Day 1
Optical Coherence Tomography (OCT) test in Part 1A and 2
Time Frame: Day 1
To assess the visual function
Day 1
Visual acuity test with Early Treatment Diabetic Retinopathy Study (ETDRS) in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function
Up to week 8
Visual acuity test with ETDRS in Part 1B
Time Frame: Day 1
To assess the visual function
Day 1
The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function and the quality of life (QOL)
Up to week 8
The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11) in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function and QOL
Up to week 8
Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2
Time Frame: Up to week 8
To assess the psychological adjustment
Up to week 8
Daily living task dependent on vision (DLTV) in Part 1A and 2
Time Frame: Up to week 8
To assess QOL
Up to week 8
Table test in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function
Up to week 8
Metropsis test in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function
Up to week 8
Low vision evaluator (LoVE) in Part 1A
Time Frame: Up to week 8
To assess the visual function
Up to week 8
White flash visual evoked potential (VEP) test in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function
Up to week 8
White flash VEP test in Part 1B and 3
Time Frame: Day 1
To assess the visual function
Day 1
Color flash VEP test in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function
Up to week 8
Color flash VEP test in Part 1B and 3
Time Frame: Day 1
To assess the visual function
Day 1
Electrically evoked response (EER) test in Part 1A and 2
Time Frame: Up to week 8
To assess the visual function
Up to week 8
EER test in Part 1B and 3
Time Frame: Day 1
To assess the visual function
Day 1
White flash electroretinography test in Part 1A, 1B, 2 and 3
Time Frame: Day 1
To assess the visual function
Day 1
Pupillary function test in Part 2
Time Frame: Up to week 8
To assess the visual function
Up to week 8
Pupillary function test in Part 1B and 3
Time Frame: Day 1
To assess the visual function
Day 1
Full field stimulus threshold testing (FST) in Part 2
Time Frame: Up to week 8
To assess the visual function
Up to week 8
FST in Part 1B
Time Frame: Day 1
To assess the visual function
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRE170041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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