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Trial History Detail on 2017-11-14

CUHK_CCRB00563

2017-09-05

Prospective

2017.025

ITS/172/16

Innovation and Technology Fund

The Innovation and Technology Commission

N/A

Not Applicable

Lok Yiu Yeung

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

3943 5870

yeungly@cuhk.edu.hk

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

Hong Kong

Kam Lung Kelvin Chong

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

39435805

chongkamlung@cuhk.edu.hk

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

Hong Kong, China

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

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

三維打印技術於外科手術儀器及眼眶模型之應用

3SIOM

Hong Kong

Yes

2017-08-18

Joint CUHK-NTEC Clinical Research Ethics Committee

2017.025

socket orbital trauma

Procedure

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.

N/A

N/A

N/A

N/A

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.

N/A

N/A

N/A

N/A

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

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

18

999

Both Male and Female

Interventional

Non-randomized

Uncontrolled

Open label

Single group

Other

Not applicable

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.

2017-09-15

10

Not Yet Recruiting

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.

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

6 months after surgery

N/A

N/A

N/A

No

2018-11-16

ChiCTR-OOC-17012632

2017-09-05

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