Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001342404
Ethics application status
Approved
Date submitted
25/08/2016
Date registered
26/09/2016
Date last updated
26/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hole Closure in Vitrectomy with internal limiting membrane repositioning and autologous blood for Macular hole retinal detachment repair in High myopes
Scientific title
Hole Closure in Vitrectomy with internal limiting membrane repositioning and autologous blood for Macular hole retinal detachment repair in High myopes
Secondary ID [1] 289972 0
NA
Universal Trial Number (UTN)
U1111-1186-8489
Trial acronym
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Macular hole retinal detachment in high myopes 299974 0
Condition category
Condition code
Eye 299865 299865 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective interventional cohort study of 30 eyes of 30 consecutive patients with high myopia and MHRD if they satisfy the inclusion and exclusion criteria, will be invited to join the study and if they agree, will sign the consent form.
Best-corrected visual acuity, refraction, slit lamp examination, lens status, intraocular pressure, fundus examination, fundus photo, axial length and optical coherence tomography findings will be documented before surgery.

All patients will be operated under regional or general anaesthesia by the investigators.

Combined cataract surgery and intraocular lens implantation will be done when indicated.

Standard 3-port 23G vitrectomy followed by Internal limiting membrane (ILM) peeling with ILM Blue and with remnants at the hole edge for creation of an ILM clump repositioned into the macular hole. Fresh blood will be obtained from the patient’s antecubital vein, and injected gently to cover the macular hole. The fresh blood will soon become a clot on the surface of the repositioned ILM filling the macular hole, and seal it. Air-fluid exchange will be done without intentional drainage of subretinal fluid through the macular hole. In cases of extensive retinal detachment extending well beyond the vascular arcades, an extramacular retinotomy may be created at the discretion of the investigator to drain subretinal fluid to facilitate further procedures such as laser photocoagulation. Gas-air exchange will be performed with gas tamponade by 12-14% C3F8 at the end of surgery.

Postoperatively, the patients will be asked to remain in a prone position for 3 days and to avoid the supine position afterward during the follow-up period until the gas is absorbed.

Procedure is performed by an experienced vitreoretinal surgeon. The approximate duration of the procedure is about 90 minutes.
Intervention code [1] 295665 0
Treatment: Surgery
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299340 0
Macular hole closure (assessed by optical coherence tomography)
Timepoint [1] 299340 0
1 year post-surgery
Primary outcome [2] 299632 0
retinal reattachment (assessed by optical coherence tomography)
Timepoint [2] 299632 0
1 year post-surgery
Secondary outcome [1] 326892 0
Best corrected visual acuity (BCVA) which is assessed using ETDRS chart to obtain logMAR (logarithm of minimum angle of resolution) BCVA.
Timepoint [1] 326892 0
baseline and 1 year post-surgery

Eligibility
Key inclusion criteria
1. Patients with macular hole retinal detachment (MHRD) with highly myopic eyes (defined as greater than or equal to 6D diopters or axial length greater than or equal to 26.5mm)
2. Age more than 18 years old
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of retinal detachment (RD) or proliferative vitreoretinopathy (PVR)
2. History of intraocular surgery, with the exception of retinal laser photocoagulation or peripheral iridotomy, and cataract surgery
3. Macular hole secondary to other causes
4. Diabetic retinopathy, vitreous haemorrhage, retinal vascular occlusion, uveitis, trauma, optic atrophy, glaucoma, or corneal opacity.
5. Patients who cannot comply with any facedown positioning

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparison between different time periods, e.g. final visit and baseline visit, will be made using ANOVA with repeated measures and Post hoc test using Bonferroni adjusted, or Friedman test and Wilcoxon signed rank tests as appropriate.

From the retrospective study first reporting this new surgical technique of vitrectomy and inverted ILM repositioning and autologous blood clot to treat MHRD in high myopes, the macular hole closure rate was 96%, and that study examined retrospective data in 27 eyes of 27 patients.

We plan to prospectively evaluate 30 eyes of 30 consecutive patients to further evaluate the anatomical hole closure, and correlate with functional outcomes for this surgical technique.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/06/2016
Date of last participant enrolment
Anticipated
31/12/2017
Actual
Date of last data collection
Anticipated
31/12/2018
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 8113 0
Hong Kong
State/province [1] 8113 0

Funding & Sponsors
Funding source category [1] 294345 0
Government body
Name [1] 294345 0
Kowloon Central Cluster Grant
Country [1] 294345 0
Hong Kong
Primary sponsor type
Government body
Name
Kowloon Central Cluster Grant
Address
REC Office
Room 808, Block S, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 293183 0
None
Name [1] 293183 0
Not applicable
Address [1] 293183 0
Not applicable
Country [1] 293183 0
Other collaborator category [1] 279174 0
University
Name [1] 279174 0
Department of Ophthalmology & Visual Sciences, the Chinese University of Hong Kong
Address [1] 279174 0
3/F,. Hong Kong Eye Hospital, 147K Argyle Street, Hong Kong Eye Hospital, Kowloon, Hong Kong
Country [1] 279174 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295762 0
Research Ethics Committee (Kowloon Central/ Kowloon East)
Ethics committee address [1] 295762 0
REC Office
Room 808, Block S, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong
Ethics committee country [1] 295762 0
Hong Kong
Date submitted for ethics approval [1] 295762 0
08/12/2015
Approval date [1] 295762 0
10/05/2016
Ethics approval number [1] 295762 0
KC/KE-15-0213/FR-1

Summary
Brief summary
Methods: This study is a prospective cohort study
Institution: Hong Kong Eye Hospital
The purpose of this study is to evaluate the reconstructive process of anatomical hole closure and functional outcomes of a novel surgical strategy- vitrectomy with inverted internal limiting membrane (ILM) repositioning and autologous blood clot for macular hole retinal detachment (MHRD) in highly myopic eyes.
No prospective study has been done so far, and this study can provide new data on microstructural imaging analysis of hole closure by optical coherence tomography (OCT) imaging and functional outcomes of the above surgical technique, can increase understanding of the process and mechanisms of macular hole closure in MHRD in highly myopic eyes, and fill the gap in the literature.
Trial website
Not applicable
Trial related presentations / publications
Study not yet completed hence not yet applicable
Public notes

Contacts
Principal investigator
Name 68386 0
Dr TSANG Chi Wai
Address 68386 0
3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong
Country 68386 0
Hong Kong
Phone 68386 0
+85239435825
Fax 68386 0
Email 68386 0
[email protected]
Contact person for public queries
Name 68387 0
Ms Janice WONG
Address 68387 0
3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong
Country 68387 0
Hong Kong
Phone 68387 0
+85239435825
Fax 68387 0
Email 68387 0
[email protected]
Contact person for scientific queries
Name 68388 0
Dr TSANG Chi Wai
Address 68388 0
3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong
Country 68388 0
Hong Kong
Phone 68388 0
+85239435825
Fax 68388 0
Email 68388 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.