Trial Review

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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
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?
Secondary ID [1] 282179 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HBOT induced myopia 288692 0
Condition category
Condition code
Eye 289040 289040 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 286787 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 289153 0
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.
Timepoint [1] 289153 0
Baseline, completion of 20 sessions of HBOT, 4 weeks and 12 weeks post-treatment
Primary outcome [2] 289174 0
Ocular refractive change (autorefraction) will be assessed in patients of both arms using an autorefractor
Timepoint [2] 289174 0
Baseline, Completion of 20 HBOT sessions, 4 weeks and 12 weeks post-treatment
Primary outcome [3] 289175 0
Ocular refraction (subjective refraction) will be assessed in patients of both arms by a qualified orthoptist assisting in the study
Timepoint [3] 289175 0
Baseline, Completion of 20 HBOT sessions, 4 weeks and 12 weeks post-treatment
Secondary outcome [1] 301937 0
Corneal curvature will be assessed using a keratometer.
Timepoint [1] 301937 0
Baseline, Completion of 20 HBOT sessions, 4 weeks and 12 weeks post-treatment

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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refusal to participate
Patients using topical eye treatments

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)
Patients indicated for HBOT are recruited based on the inclusion/exclusion criteria.
Allocation involved contacting the holder of the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random permuted blocks
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 792 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 6611 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 286947 0
Self funded/Unfunded
Name [1] 286947 0
Nil
Country [1] 286947 0
Primary sponsor type
Individual
Name
Michael Bennett
Address
The Prince of Wales Hospital,
Barker Street, Randwick,
NSW 2031
Country
Australia
Secondary sponsor category [1] 285734 0
None
Name [1] 285734 0
Address [1] 285734 0
Country [1] 285734 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289000 0
South Eastern Sydney Local Health District HREC (Northern Sector)
Ethics committee address [1] 289000 0
Research Support Office G71 East Wing, Edmund Blacket Building Prince of Wales Hospital Cnr High and Avoca Streets RANDWICK NSW 2031
Ethics committee country [1] 289000 0
Australia
Date submitted for ethics approval [1] 289000 0
15/06/2010
Approval date [1] 289000 0
01/11/2011
Ethics approval number [1] 289000 0
10/128

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38710 0
A/Prof Michael Bennett
Address 38710 0
Department of Diving and Hyperbaric Medicine
The Prince of Wales Hospital,
Barker Street,
Randwick, NSW 2031
Country 38710 0
Australia
Phone 38710 0
+61293823880
Fax 38710 0
Email 38710 0
m.bennett@unsw.edu.au
Contact person for public queries
Name 38711 0
A/Prof Michael Bennett
Address 38711 0
Department of Diving and Hyperbaric Medicine
The Prince of Wales Hospital,
Barker Street,
Randwick, NSW 2031
Country 38711 0
Australia
Phone 38711 0
+61293823880
Fax 38711 0
Email 38711 0
m.bennett@unsw.edu.au
Contact person for scientific queries
Name 38712 0
A/Prof Michael Bennett
Address 38712 0
Department of Diving and Hyperbaric Medicine
The Prince of Wales Hospital,
Barker Street,
Randwick, NSW 2031
Country 38712 0
Australia
Phone 38712 0
+61293823880
Fax 38712 0
Email 38712 0
m.bennett@unsw.edu.au

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.