Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001134819
Ethics application status
Approved
Date submitted
31/05/2010
Date registered
24/10/2012
Date last updated
24/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of glucose on contrast sensitivity in human glaucoma.
Scientific title
The effect of glucose on contrast sensitivity in human glaucoma: A prospective, randomised, double-masked pilot study.
Secondary ID [1] 251856 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 257457 0
Condition category
Condition code
Eye 257603 257603 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: The study eye will receive a drop of sterile 50% glucose (10 Microlitres) every 5 minutes for one hour. Pain and discomfort will be assessed through out the period of treatment. It will be assessed on a pain scale of 1 to 10. 1 being nil pain and 10 being the worst pain. This will be documented in the patient's case notes.


Sham control: on another visit separated by at least one week, the same patients will receive a saline drop in the same manner, and undergo the same tests. (The optic disc photo is important to record the subtype of glaucomatous optic neuropathy in case there is a clear pattern, but does not need repeating.)
Intervention code [1] 256547 0
Treatment: Drugs
Comparator / control treatment
Group A is the intial study group of 16 non-diabetic subjects with moderate to severe glaucoma.
Group B is the second study group of 6 non-diabetic subjects without any history of glaucoma.
Both Group A and B will have a visit with the instillation of Glucose drops and another visit with saline drops as the placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 258517 0
Contrast Sensitivity
Timepoint [1] 258517 0
10 minutes after the last drop (either glucose or saline) instillation, the baseline measurements will be repeated in the same order. Any change in refraction will be corrected. The primary outcome will be the change in the Contrast Sensitivity measurement at 12 cycles per degree compared to baseline. This single outcome was chosen based on previous data showing an improvement in this parameter after IOP reduction, and to avoid reductions in the alpha value due to multiple hypothesis testing.

The contrast sensitivity in this study is measured using the Vector Vision CSV -1000 E illuminated chart.
Secondary outcome [1] 264326 0
Automated field analysis will be performed with the zeiss humphrey AVF machine.
Timepoint [1] 264326 0
Recorded at the end of each treatment visit.

Eligibility
Key inclusion criteria
Group A
Inclusion Criteria:
Age 50 years or older
Pseudophakic,
moderate to severe glaucoma (MD < -6)
Visual acuity logMAR < 1.0
Group B
Inclusion Criteria:
Age 50 years or older
Pseudophakic
Visual acuity logMAR < 1.0
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Group A
Exclusion Criteria:
History of diabetes mellitus
Group B

History of diabetes mellitus
Glaucoma

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. Randomization was coducted off site by a computer program.
2. Numbered opaque envelopes delivered to site.
3. Subjects then randomized in order of number on envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
after informed consent at the screening visit, the most severely affected eye will be randomized to receive either treatment (T) followed by sham (S) or vice versa; i.e. either TS or ST. Patients will be masked to the treatment and the investigator measuring CS will also be masked to treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The main experiment is a repeated measures crossover study. This study can exploit the benefits of a crossover design without suffering disadvantages. The main potential disadvantage of a crossover design is persistence of the treatment effect, but due to the short-acting nature of the intervention, there will be no carry over effect. The crossover design effectively halves the numbers required and eliminates any confounding covariates. Using an ANCOVA analysis of the difference in CS between treatment and sham with an estimated correlation of 0.7 between the baseline and post-treatment and a mean difference of .3 with a standard deviation of .35 (based on previous data).
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257044 0
Self funded/Unfunded
Name [1] 257044 0
Robert Casson
Country [1] 257044 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Tce
ADELAIDE SA 5000
Country
Australia
Secondary sponsor category [1] 256302 0
None
Name [1] 256302 0
Address [1] 256302 0
Country [1] 256302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259103 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 259103 0
Lev 3 Hanson Institute
Institute Medical Vetinary Services (IMVS)
Royal Adelaide Hospital
North Tce
ADELAIDE SA 5000
Ethics committee country [1] 259103 0
Australia
Date submitted for ethics approval [1] 259103 0
02/06/2010
Approval date [1] 259103 0
03/05/2012
Ethics approval number [1] 259103 0
120418

Summary
Brief summary
The purpose of this study is to improve visual outcomes for patients who suffer with glaucoma. This outcome is known as contrast sensitivity.

Glaucoma: is a disease in which the optic nerve is damaged, leading to progressive, irreversible loss of vision. It is often, but not always, associated with increased pressure of the fluid in the eye.

The purpose of this study is to establish a proof of a principle known as neuroprotection.

Neuroprotection: refers to the ability to directly promote survival of the optic nerve.
The optic nerve is the nerve that transmits visual information from the retina to the brain.

Contrast sensitivity: is the ability to differentiate between light and dark (contrast).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31216 0
Address 31216 0
Country 31216 0
Phone 31216 0
Fax 31216 0
Email 31216 0
Contact person for public queries
Name 14463 0
Kylie Dansie
Address 14463 0
Ophthalmology Network
East Wing, Lev 8
Royal Adelaide Hospital
North Tce
ADELAIDE SA 5000
Country 14463 0
Australia
Phone 14463 0
+61 8 8222 2732
Fax 14463 0
+61 8 8222 2741
Email 14463 0
[email protected]
Contact person for scientific queries
Name 5391 0
Robert Casson
Address 5391 0
Ophthalmology Network
East Wing, Lev 8
Royal Adelaide Hospital
North Tce
ADELAIDE SA 5000
Country 5391 0
Australia
Phone 5391 0
+61(0)418857813
Fax 5391 0
+61 8 8222 2741
Email 5391 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseEffect of subconjunctival glucose on retinal ganglion cell survival in experimental retinal ischaemia and contrast sensitivity in human glaucoma.2016https://dx.doi.org/10.1111/ceo.12581
Dimensions AIGlucose-Induced Temporary Visual Recovery in Primary Open-Angle Glaucoma A Double-Blind, Randomized Study2014https://doi.org/10.1016/j.ophtha.2013.12.011
N.B. These documents automatically identified may not have been verified by the study sponsor.