Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000475640
Ethics application status
Approved
Date submitted
30/04/2014
Date registered
7/05/2014
Date last updated
7/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Retinal blood vessels in sleep apnea patients
Scientific title
Retinal vascular complications in obstructive sleep apnea patients
Secondary ID [1] 284506 0
Nil
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 291765 0
Condition category
Condition code
Eye 292123 292123 0 0
Diseases / disorders of the eye
Respiratory 292124 292124 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Non-invasive optical scanning of the retina. This will take approximately 15 minutes and will be a one-off scan.
Intervention code [1] 289264 0
Not applicable
Comparator / control treatment
Aged matched health volunteers
Control group
Active

Outcomes
Primary outcome [1] 292003 0
Increased pulsatility index of retinal vessels in OSA patients. This will be assessed using post data capture analysis on retinal videos recorded from each individual. The pulse amplitude of both retinal artery and veins will be measured using custom algorithms in OSA and controls.
Timepoint [1] 292003 0
cross-sectional study, assessed at baseline only. We aim to recruit the target number of participants within 3 years.
Secondary outcome [1] 307984 0
Need of ocular screening for OSA patients. If significant results are obtained, using methodology described in the primary outcome a screening tool may be developed to screen the eyes in OSA patients for early diagnosis
Timepoint [1] 307984 0
3 years

Eligibility
Key inclusion criteria
1. OSA patients undergoing overnight diagnostic polysomnography will be included
2. Gender: M/F
3. Age range: 18+
4. Clear ocular media with visual acuity >= 6/12.
5. Not on previous ocular study trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
2. Participants with a history of ocular disease(s) that are likely to interfere with the metabolism or excretion of test medications.
3. Participants with a history of a psychological illness or other conditions which may interfere with their ability to understand the study requirements.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis
We will perform statistical analysis once we have recruited the target number of participants.
Our previous study on glaucoma and control subjects showed a mean difference of 8mm/s, 15 micrometers, 10% and 20 micrometers for retinal pulse wave propagation, vessel diameter, pulsatility index and retinal nerve fibre layer thickness respectively, between the two groups. Based on this, we computed the average effect size to be 0.3. With type-I error (alpha) of 0.05 and power of 0.95, a sample size of ~100 (50 in each group) will be sufficient to detect a difference between these two groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/05/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2367 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 8034 0
2113 - North Ryde
Recruitment postcode(s) [2] 8035 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 289149 0
University
Name [1] 289149 0
Macquarie University
Country [1] 289149 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, North Ryde NSW 2113
Country
Australia
Secondary sponsor category [1] 287815 0
None
Name [1] 287815 0
Address [1] 287815 0
Country [1] 287815 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290922 0
Macquarie University Human Research
Ethics committee address [1] 290922 0
Balaclava Rd, North Ryde, NSW 2109
Ethics committee country [1] 290922 0
Australia
Date submitted for ethics approval [1] 290922 0
Approval date [1] 290922 0
28/04/2014
Ethics approval number [1] 290922 0
5201400103

Summary
Brief summary
Obstructive sleep apnea (OSA) is a condition consisting of intermittent upper airway obstruction during sleep, leading to periods of hypoxia (reduced oxygen levels) and acute hypertension (high blood pressure). It has been hypothesized that in OSA, physiological changes can result in retinal ischemia (restriction in blood supply to tissues) and associated retinal vascular changes and progression of glaucomatous damage to the optic nerve. In a previous study, we did not find an increased prevalence of optic disc edema or other optic neuropathies in the OSA population. However, retinal vascular changes were more common in patients with severe OSA, independent of blood pressure, suggesting that OSA patients should undergo ophthalmologic screening. Despite this, the risk for various ocular disorders among patients with OSA remains unclear, particularly because in prior studies only static (single) measures of retinal vessels were considered. Additionally, these studies did not adequately control for potential confounders of these associations, such as obesity and hypertension. The aim of the current study is to investigate dynamic (real time videos) retinal vasculature characteristics in OSA patients and determine any associated changes of the retina in this group of patients. This will provide a new-insight into specific OSA related changes in the eye.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 43 43 0 0
/AnzctrAttachments/366234-APPROVED_FRASER_5201400103_2.pdf

Contacts
Principal investigator
Name 47994 0
Dr Clare Fraser
Address 47994 0
Macquarie Eye Clinic, 2 Technology Place, Macquarie University, NSW 2109
Country 47994 0
Australia
Phone 47994 0
+61 2 9812 3933
Fax 47994 0
Email 47994 0
[email protected]
Contact person for public queries
Name 47995 0
Dr Mojtaba Golzan
Address 47995 0
Australian School of Advanced Medicine
2 Technology Place, Macquarie University
NSW 2109
Country 47995 0
Australia
Phone 47995 0
+61 2 9850 2759
Fax 47995 0
Email 47995 0
[email protected]
Contact person for scientific queries
Name 47996 0
Dr Mojtaba Golzan
Address 47996 0
Australian School of Advanced Medicine
2 Technology Place, Macquarie University
NSW 2109
Country 47996 0
Australia
Phone 47996 0
+61 2 9850 2759
Fax 47996 0
Email 47996 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
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