Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000826246
Ethics application status
Approved
Date submitted
14/10/2008
Date registered
22/09/2009
Date last updated
29/11/2019
Date data sharing statement initially provided
29/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Light restriction in retinal degeneration
Scientific title
Light restriction in retinal degeneration and potential to slow visual loss
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinal degenerations in particular retinitis pigmentosa 3829 0
Condition category
Condition code
Eye 4017 4017 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 They will be asked to wear an occluding lens (This is an eye patch that fits over the wearers glasses or sticks to the skin if the participant doesn't wear glasses these are the same as what children who have amblyopia "lazy eye" wear) on one eye for up to 12 weeks.
1a. The patch is worn full time during waking hours. There are two exceptions firstly for bathing/ showering and secondly for driving a car. The total time the patch is off should be less than 1 hour.
Intervention code [1] 3552 0
Treatment: Other
Comparator / control treatment
The other eye will provide an internal control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4918 0
An improvement in Electrophysiology parameters. The parameters measured are: Dark Rod, Maximum rod, Single flash cone, 30Hz flicker and Fused flicker parameters on the Electroretinogram and Dark Adaptation
Timepoint [1] 4918 0
They will be tested on three occasions before beginning the trial, and at 1w, 2w, 4w, 8w and 12 w after beginning the wearing of the occluder.
Secondary outcome [1] 8301 0
Full threshold Visual field will be measure using the Humphrey automated perimeter on a 24-2 test
Timepoint [1] 8301 0
They will be tested on three occasions before beginning the trial, and at 1w, 2w, 4w, 8w and 12 w after beginning the wearing of the occluder.

Eligibility
Key inclusion criteria
1.Subjects will have a diagnosis of retinal degeneration, with the following admission criteria:
Rod-cone dystrophy, non-syndromic
Age 18-35
Flash Electroretinogram (ERG) still detectable
Dark-adapted thresholds at least 20% of normal
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Free of significant other ophthalmic pathology (eg cataract macular oedema or glaucoma)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Uncovered eye will be internal control
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
No patients were recruited
Date of first participant enrolment
Anticipated
1/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 4010 0
University
Name [1] 4010 0
Save Sight Institute, Sydney University
Country [1] 4010 0
Australia
Primary sponsor type
Individual
Name
Dr John Grigg
Address
Save Sight Institute
Sydney University
Sydney Eye Hospital Campus
Macquarie Street
Sydney NSW 2001
Country
Australia
Secondary sponsor category [1] 3602 0
Individual
Name [1] 3602 0
Prof Jonathan Stone
Address [1] 3602 0
Save Sight Institute
Sydney University
Sydney Eye Hospital Campus
Macquarie Street
Sydney NSW 2001
Country [1] 3602 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6090 0
Sydney University
Ethics committee address [1] 6090 0
Camperdown
Sydney NSW 2006
Ethics committee country [1] 6090 0
Australia
Date submitted for ethics approval [1] 6090 0
Approval date [1] 6090 0
01/08/2008
Ethics approval number [1] 6090 0

Summary
Brief summary
Studies in animals with retinal dystrophies shows benefit from light restriciton. In particular improvement in retinal function as measured by an elecroretinogram. This study is being undertaken to see if restricting light exposure in people with retinal dystrophies improves retinal function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29037 0
Prof Johnathan Stone
Address 29037 0
Save Sight Institute Sydney University Sydney Eye Hospital Campus Macquarie Street Sydney NSW 2001
Country 29037 0
Australia
Phone 29037 0
+61293827111
Fax 29037 0
Email 29037 0
jonathan.stone@anu.edu.au
Contact person for public queries
Name 12194 0
A/Prof Dr John Grigg
Address 12194 0
Save Sight Institute
Sydney University
Sydney Eye Hospital Campus
Macquarie Street
Sydney NSW 2001
Country 12194 0
Australia
Phone 12194 0
+61 2 93827302
Fax 12194 0
+61 2 93827372
Email 12194 0
johng@eye.usyd.edu.au
Contact person for scientific queries
Name 3122 0
Prof Prof Jonathan Stone
Address 3122 0
Save Sight Institute
Sydney University
Sydney Eye Hospital Campus
Macquarie Street
Sydney NSW 2001
Country 3122 0
Australia
Phone 3122 0
+61 2 93827302
Fax 3122 0
+61 2 93827372
Email 3122 0
Jonathan Stone [jonathan.stone@anu.edu.au]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.