Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000179932
Ethics application status
Approved
Date submitted
1/02/2011
Date registered
15/02/2011
Date last updated
5/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A single centre, prospective, non-randomised, non-comparative interventional case series investigating the efficacy of direct corneal neurotization using supraorbital and supratrochlear nerves in patients with
anaesthetic cornea.
Scientific title
Direct corneal neurotization of anaesthetic cornea.
Non comparative study to evaluate the efficacy of direct corneal neurotization using supraorbital and supratrochlear nerves in patients with anaesthetic cornea.
Secondary ID [1] 253491 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthetic cornea 261041 0
Condition category
Condition code
Eye 259181 259181 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To evaluate the efficacy of direct corneal neurotization using supraorbital and supratrochlear nerves in patients with anaesthetic cornea.
Through a bicoronal incision, the supratrochlear and supraorbital nerves will be identified and carefully dissected under high magnification.
The nerve branches will then be tunnelled over the nasal bridge to a small incision along the lid crease of the upper lid of the contralateral anaesthetic eye.
Under the operating microscope, the distal nerve branches will be retrieved with a fine hemostat inserted through a tiny incision under the upper lid.
The eye will then be directed downward using a superior rectus tendon traction suture.
An incision through the superior bulbar conjunctiva 7mm behind the superonasal position of the corneal limbus will be made.
In the potential space between where the sclera and Tenon’s capsule are juxtaposed to the anatomical corneal limbus, a tunnel will be created by blunt dissection using curved scissors around the circumference of the corneal limbus both temporally and nasally to the points of planned insertion of the prepared nerves.
The distal nerve branches will be passed into the prepared perilimbal space, fanned and sutured into place in the conjunctival sac next to the corneal limbus with 10-0 monofilament nylon sutures under direct high magnification.
The overall surgery time will be approximately 45 minutes.
Intervention code [1] 257925 0
Treatment: Surgery
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262033 0
Corneal sensibility stratified by sectors at 6 years.Assessments made using esthesiometry and a Corneal neurotization Patients "psychosocial questionnaire"(adapted from Terzis JK,Dryer MM,Bodner BI.Corneal neurotization:a novel technique for the anesthetic cornea.2010 Jul;29(7);812-9).
Timepoint [1] 262033 0
4 weeks,12 months then yearly for 6 years
Secondary outcome [1] 273042 0
Best corrected visual acuity up to 6 years.Assessments made using Snellen chart.
Timepoint [1] 273042 0
4 weeks,12 months then yearly for 6 years
Secondary outcome [2] 273043 0
Incidence of complicatons up to 6 years. Examples are 1 case of post operative subgaleal haematoma requiring drainage and presure dressing.1 case of neuroma that did not require any intervention.Numbness of the opposite forehead typically last for 3 months after the surgery.Assessments made using eye examination.
Timepoint [2] 273043 0
4 weeks,12 months then yearly for 6 years
Secondary outcome [3] 273044 0
Progress of neurotrophic keratopathy.Assessments made using eye examination and esthesiometry.
Timepoint [3] 273044 0
4 weeks,12 months then yearly for 6 years

Eligibility
Key inclusion criteria
All patients with global anaesthetic corneas as confirmed by clinical examination and esthesiometry.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with transient causes of neurotrophic keratopathy e.g. Corneal anesthesia post LASIK, radiotherapy induced neurotrophic keratopathy
Patients with condition that may affect healing or not amendable to neurotization e.g. focal anaesthetic cornea, band keratopathy, conjunctival disease, previous corneal surgery, significant subepithelial stromal scar
Patients that intervention may preclude future sight preserving operation to the eye e.g. glaucoma which may require filtration surgery
Patients with systemic illness that precludes operation

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 anaesthetic corneas will undergo clinical and ophthalmological examination. We plan to recruit patients fulfilling the inclusion criteria over 12 months. Baseline severity of neurotrophic keratopathy is recorded and staged. Baseline degree of cornea anaesthesia will be recorded on a 5 zone map. Only patients with global anaesthetic corneas confirmed by clinical examination and testing (esthesiometry) and deemed suitable for corneal neurotization will be included in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258409 0
Hospital
Name [1] 258409 0
Royal Adelaide Hospital
Country [1] 258409 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Level 8, East Wing
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 257560 0
None
Name [1] 257560 0
Address [1] 257560 0
Country [1] 257560 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260381 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 260381 0
Ethics committee country [1] 260381 0
Australia
Date submitted for ethics approval [1] 260381 0
02/02/2011
Approval date [1] 260381 0
Ethics approval number [1] 260381 0

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

Contacts
Principal investigator
Name 32140 0
Address 32140 0
Country 32140 0
Phone 32140 0
Fax 32140 0
Email 32140 0
Contact person for public queries
Name 15387 0
Dr Weng Onn Chan
Address 15387 0
Level 8 East Wing
Royal Adelaide Hospital
North Terrace
SA 5000
Country 15387 0
Australia
Phone 15387 0
+61 8 8222 2729
Fax 15387 0
Email 15387 0
[email protected]
Contact person for scientific queries
Name 6315 0
Dr Weng Onn Chan
Address 6315 0
Level 8 East Wing
Royal Adelaide Hospital
North Terrace
SA 5000
Country 6315 0
Australia
Phone 6315 0
+61 8 8222 2729
Fax 6315 0
Email 6315 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.