Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00563

2 Trial Registration Date

2017-09-05

i Registration Status

Prospective

3 Secondary IDs

2017.025

ITS/172/16

4 Source(s) of Funding

Innovation and Technology Fund

5 Primary Sponsor

The Innovation and Technology Commission

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Lok Yiu Yeung

ii Address

DOVS, 4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

iii Phone

3943 5870

iv Email

yeungly@cuhk.edu.hk

v Affiliation

Department of Ophthalmology & Visual Sciences, The Chinese Univsersity of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Kam Lung Kelvin Chong

ii Address

DOVS, 4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

iii Phone

39435805

iv Email

chongkamlung@cuhk.edu.hk

v Affiliation

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

vi Country

Hong Kong, China

9 Official Scientific Title of the Study

3D-printed Surgical Instruments and Orbital Models (3SIOM)

10 Public Title

3D-printed Surgical Instruments and Orbital Models (3SIOM)

i Public Title in Chinese 研究名稱

三維打印技術於外科手術儀器及眼眶模型之應用

11 Short Title (Optional)

3SIOM

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-08-18

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.025

14 Medical Condition Being Studied

socket orbital trauma

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

An ergonomically-friendly tissue retractor and a pair of implant contouring negative mould which are specific to the patients are produced with 3D printing technology.

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

N/A

vi Frequency of the intervention

N/A

16 Comparative Treatments

i Description/ name of comparative treatments

Patients in Hong Kong requiring orbital fracture repair have only access to commercially available factory-made flat sheets or prebent orbital implants, the latter based on average Caucacian parameters. None of these items is patient- or Asian-specific.

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients with post-trauma orbital fracture with one or more of the following criteria:

primary or down-gaze diplopia

>=2mm enophthalmos

Persistent infraorbital numbness

>50% orbital wall involvement

ii Exclusion Criteria

Prior history of orbital diseases, trauma, radiotherapies or surgeries or other confounding conditions, or fail to provide informed consent will be excluded.

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Other

Please specify

Not applicable

vi Study Objectives (Optional)

The objective of this project is to explore the use of three-dimensional printing(3DP) technology in eye-socket (orbital) trauma. We plan to manufacture patient-specific instruments and implant moulds for orbital fracture repair, currently not available in the market.

20 Anticipated trial start date

2017-09-15

21 Target Sample Size

10

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

The intraoperative time, attempts and difficulties during tissue retraction and implant contouring, as well as the intraoperative gap between bony margins and the implant and the presence of prolapsing tissues.

ii The metric or method of measurement used

Report by surgeon and attedning doctors of the follow-up visit

iii The timepoint(s) of primary interest

6 months after surgery

24 Secondary Outcome

i The Name of the outcome

N/A

ii The metric or method of measurement used

N/A

iii The timepoint(s) of primary interest

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-11-16

27 Primary Registry and Trial Identifying Number

ChiCTR-OOC-17012632

28 Date of Registration in Primary Registry

2017-09-05

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Trial History Detail on 2017-11-14