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Trial registered on ANZCTR
Registration number
ACTRN12613000343707
Ethics application status
Approved
Date submitted
25/03/2013
Date registered
28/03/2013
Date last updated
29/07/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Changes to visual acuity (clearness of vision) after Hyperbaric Oxygen Therapy
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Scientific title
For patients receiving the standard protocol of Hyperbaric Oxygen Therapy (HBOT), does the delivery of oxygen via hood induce a greater extent of ocular refractive change in patients than in patients who received oxygen via mask?
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Secondary ID [1]
282179
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Nil
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Universal Trial Number (UTN)
Nil
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HBOT induced myopia
288692
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Condition category
Condition code
Eye
289040
289040
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0
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients are administered a minimum of 20 sessions of hyperbaric oxygen therapy (HBOT) in a multiplace chamber. Each session involves the delivery of 100% oxygen at 2.4ATA, for 90 minutes.
Sessions will be administered once everyday consecutively (Mon-Fri), for a minimum of 20 sessions, up to 40 sessions (i.e. 20-40 working days)
Patients in the intervention group will receive oxygen via a plastic hood that encloses the head. This creates a seal for oxygen to accumulate, allowing patients to breathe in 100% oxygen.
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Intervention code [1]
286787
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Treatment: Devices
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Comparator / control treatment
Patients are administered a minimum of 20 sessions of hyperbaric oxygen therapy (HBOT) in a multiplace chamber. Each session involves the delivery of 100% oxygen at 2.4ATA, for 90 minutes.
Sessions will be administered once everyday consecutively (Mon-Fri), for a minimum of 20 sessions, up to 40 sessions (i.e. 20-40 working days)
Patients in the control group will receive oxygen via a mask that forms a seal over the patient's nose and mouth.
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Control group
Active
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Outcomes
Primary outcome [1]
289153
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Best corrected visual acuity is assessed in patients of both arms, using the Snellen chart. Patients are required to don their prescription eyewear when being assessed.
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Assessment method [1]
289153
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Timepoint [1]
289153
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Baseline, completion of 20 sessions of HBOT, 4 weeks and 12 weeks post-treatment
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Primary outcome [2]
289174
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Ocular refractive change (autorefraction) will be assessed in patients of both arms using an autorefractor
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Assessment method [2]
289174
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Timepoint [2]
289174
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Baseline, Completion of 20 HBOT sessions, 4 weeks and 12 weeks post-treatment
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Primary outcome [3]
289175
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Ocular refraction (subjective refraction) will be assessed in patients of both arms by a qualified orthoptist assisting in the study
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Assessment method [3]
289175
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Timepoint [3]
289175
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Baseline, Completion of 20 HBOT sessions, 4 weeks and 12 weeks post-treatment
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Secondary outcome [1]
301937
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Corneal curvature will be assessed using a keratometer.
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Assessment method [1]
301937
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Timepoint [1]
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Baseline, Completion of 20 HBOT sessions, 4 weeks and 12 weeks post-treatment
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Eligibility
Key inclusion criteria
HBOT indication of at least 20 sessions
Minimal visual acuity of 6/12 or better
Ability to receive HBOT via mask or hood
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patient refusal to participate
Patients using topical eye treatments
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients indicated for HBOT are recruited based on the inclusion/exclusion criteria.
Allocation involved contacting the holder of the allocation schedule.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random permuted blocks
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
19/03/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
792
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Prince of Wales Hospital - Randwick
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Recruitment postcode(s) [1]
6611
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2031 - Randwick
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Nil
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Address [1]
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Nil
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Country [1]
286947
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Primary sponsor type
Individual
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Name
Michael Bennett
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Address
The Prince of Wales Hospital,
Barker Street, Randwick,
NSW 2031
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Country
Australia
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Secondary sponsor category [1]
285734
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None
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Name [1]
285734
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Address [1]
285734
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Country [1]
285734
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289000
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South Eastern Sydney Local Health District HREC (Northern Sector)
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Ethics committee address [1]
289000
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Research Support Office G71 East Wing, Edmund Blacket Building Prince of Wales Hospital Cnr High and Avoca Streets RANDWICK NSW 2031
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Ethics committee country [1]
289000
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Australia
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Date submitted for ethics approval [1]
289000
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15/06/2010
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Approval date [1]
289000
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01/11/2011
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Ethics approval number [1]
289000
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10/128
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Summary
Brief summary
The purpose of the study is to compare the extent of refractive change in patients receiving HBOT via hood vs mask. The results will aid in the understanding of the etiology of HBOT induced myopia, and aid in choosing the delivery method of HBOT in future treatment sessions.
The investigators hypothesise greater refractive change in the hooded group, in keeping with results of previous studies.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
38710
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A/Prof Michael Bennett
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Address
38710
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Department of Diving and Hyperbaric Medicine
The Prince of Wales Hospital,
Barker Street,
Randwick, NSW 2031
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Country
38710
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Australia
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Phone
38710
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+61293823880
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Fax
38710
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Email
38710
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[email protected]
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Contact person for public queries
Name
38711
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A/Prof Michael Bennett
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Address
38711
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Department of Diving and Hyperbaric Medicine
The Prince of Wales Hospital,
Barker Street,
Randwick, NSW 2031
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Country
38711
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Australia
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Phone
38711
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+61293823880
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Fax
38711
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Email
38711
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[email protected]
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Contact person for scientific queries
Name
38712
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A/Prof Michael Bennett
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Address
38712
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Department of Diving and Hyperbaric Medicine
The Prince of Wales Hospital,
Barker Street,
Randwick, NSW 2031
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Country
38712
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Australia
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Phone
38712
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+61293823880
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Fax
38712
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Email
38712
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[email protected]
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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
No additional documents have been identified.
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