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Trial registered on ANZCTR


Registration number
ACTRN12611000832976
Ethics application status
Not yet submitted
Date submitted
19/07/2011
Date registered
8/08/2011
Date last updated
8/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Minor Salivary Gland Transplantation for Severe Dry Eye Disease
Scientific title
Minor Salivary Gland Transplantation for subjective improvement of dry eye disease and objective reduction of ocular inflammation associated with dry eye disease in patients with Severe Dry Eye Disease and healthy individuals
Secondary ID [1] 262564 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eye disease 268224 0
Condition category
Condition code
Eye 268355 268355 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The composition of saliva is very similar to tears. Minor salivary gland harvested from the lips and implanted into the eyelid to help produce saliva which alleviate dry eye disease.


Grafts of the labial/buccal mucosa with attached minor salivary glands will be taken. A full thickness mucosal graft together with attached salivary glands will be harvested and placed in povidone. As glandular density per surface area is highest in the lower lip, labial mucosa from the lower lip should be taken but the buccal and upper lip can also be used as donor site if required.

The recipient bed will be prepared by everting the lower eyelid and an injection of saline or anaesthetic will be administered to allow for separation of the conjunctiva from the underlying Muller’s muscle. An incision will be made in the lower conjunctival fornix before the graft is cut to shape and sutured into the lower conjunctival fornix. A bandage contact lens will be applied or, if this is to be avoided, grafts will be held in place with two horizontal running prolene 4-0 sutures along their upper and lower horizontal border. Both sutures will then be passed transpalpebrally out to the skin and externalised ends tied together. Antibiotic eyedrops and pressure bandages will be used for up to 1 week post-operative.

The surgery will only be performed once and will last about 120 minutes

Post-operative treatment will include application of topical antibiotics and lubricants 4-8 times daily for 2 weeks, after which sutures can be removed (if prolene used).
Intervention code [1] 266897 0
Treatment: Surgery
Comparator / control treatment
Patients having minor salivary gland transplant will be compared to healthy individuals. The healthy individuals will not receive any intervention. Tear composition will be analyzed and a standardized questionnaire is used to assess subjective symptoms of dry eye for both patients with dry eyes and healthy individuals.
Control group
Active

Outcomes
Primary outcome [1] 269125 0
(1) Score from a standardized questionnaire on subjective dry eye symptoms and functional impairment
Timepoint [1] 269125 0
1 week, 4 weeks, 12 weeks, 24 weeks and yearly for 3 years
Primary outcome [2] 269380 0
(2) Tear cytokine composition
Timepoint [2] 269380 0
1 week, 4 weeks, 12 weeks, 24 weeks and yearly for 3 years
Secondary outcome [1] 276982 0
nil
Timepoint [1] 276982 0
nil

Eligibility
Key inclusion criteria
All patients with severe DED defined by OSDI score and stage 4 dry eye severity grading scheme
Persistant severe pain and symptoms
Marked conjunctival staining
Severe corneal erosions
Flourescein tear break up time immediate (TBUT)
Schirmer score <2

Inclusion for healthy control group:
Clinically no evidence of dry eye disease
Able to attend the follow-up appointments
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age <18 years old
Pregnancy
Inability to provide consent
Previous gland graft
Existing ocular disease
Subjects using topical or systemic medications for allergies
Contact lens wearers
Smokers

Exclusion criteria for control group:
Pregnancy
Inability to provide consent
Existing ocular disease
Subjects using topical or systemic medications for allergies
Contact lens wearers
Smokers

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)
Patients with severe dry eye disease that is refractory to standard management will be offered this surgery. Patients will undergo full pre-operative work-up to assess suitability for surgery
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Dry eye symptoms and tear analysis will be compared with healthy individuals
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267370 0
Self funded/Unfunded
Name [1] 267370 0
South Australian Institute of Ophthalmology
Country [1] 267370 0
Australia
Primary sponsor type
Individual
Name
Dinesh Selva
Address
Level 8, East Wing
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 266435 0
Individual
Name [1] 266435 0
WengOnn Chan
Address [1] 266435 0
Level 8, East Wing
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country [1] 266435 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269348 0
Ethics committee address [1] 269348 0
Ethics committee country [1] 269348 0
Date submitted for ethics approval [1] 269348 0
21/07/2011
Approval date [1] 269348 0
Ethics approval number [1] 269348 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32830 0
Address 32830 0
Country 32830 0
Phone 32830 0
Fax 32830 0
Email 32830 0
Contact person for public queries
Name 16077 0
Kylie Dansie
Address 16077 0
Ophthalmology Network
Level 8 East Wing Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 16077 0
Australia
Phone 16077 0
+61 8 8222 2732
Fax 16077 0
Email 16077 0
[email protected]
Contact person for scientific queries
Name 7005 0
WengOnn Chan
Address 7005 0
Level 8, East Wing
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 7005 0
Australia
Phone 7005 0
+618 8222 2729
Fax 7005 0
Email 7005 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
No additional documents have been identified.