Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00393

2 Trial Registration Date

2014-02-04

iRegistration Status

Retrospective

3 Secondary IDs

KC/KE-13-0209/FR-3

4 Source(s) of Funding

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

5 Primary Sponsor

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

6 Secondary Sponsor

Nil

Function

Not Applicable

Please specify

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

i Name

Ms. Jennifer Tsoi

ii Address

Department of Ophthalmology and Visual Sciences,The Chinese University of Hong Kong, 3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

iii Phone

39435818

iv Email

jennifertsoi@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Prof. Tham Chee Yung Clement

ii Address

Department of Ophthalmology and Visual Sciences,The Chinese University of Hong Kong, 3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

iii Phone

39535823

iv Email

clemtham@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Combined Phacoemulsification-Endoscopic Cyclophotocoagulation versus Phacoemulsification alone in Primary Angle-Closure Glaucoma: A Randomized Controlled Trial

10 Public Title

Combined Phacoemulsification-Endoscopic Cyclophotocoagulation versus Phacoemulsification alone in Primary Angle-Closure Glaucoma: A Randomized Controlled Trial

i Public Title in Chinese 研究名稱

晶體切除手術或內鏡光凝激光聯合晶體切除手術用於治理慢性原發性閉角型青光眼之研究

11 Short Title (Optional)

Phaco-ECP vs Phacoemulsification in PACG

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-01-09

iii Full Name of IRB/IEC

Kowloon Central Cluster REC / Kowloon East Cluster REC

Please specify

iv IRB/IEC approval reference number

KC/KE-13-0209/FR-3

14 Medical Condition Being Studied

Glaucoma

15Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

-Combined Phacoemulsification-Endoscopic Cyclophotocoagulation(Phaco-ECP)
-Phacoemulsification

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

Two years

vi Frequency of the intervention

NA

16Comparative Treatments

i Description/ name of comparative treatments

Phaco-ECP is a combined operation of the standard cataract operation with the addition of an intraocular laser procedure called endoscopic cyclophotocoagulation to ablate the ciliary processes to reduce aqueous production and achieve further IOP reduction.

Phacoemulsification is a standard cataract operation involving removal of the cataratous lens and insertion of an intraocular lens.

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

Two years

v Frequency of the comparative treatments

NA

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

•A diagnosis of PACG.
•Requiring 2 or more IOP-lowering drugs to control IOP, or IOP >21mmHg on maximally tolerable drugs.
•Able and willing to give informed consent, prior to randomization.
•Older than 18 years of age.

ii Exclusion Criteria

•Previous intraocular surgery or cyclophotocoagulation, with the exception of laser peripheral iridotomy and argon laser peripheral iridoplasty.
•Secondary causes of angle closure including iridocorneal-endothelial syndrome, neovascular glaucoma etc.
•Unable to cooperate for reliable visual field and OCT examination.

iii Age Minimum

18

iv Age Maximum

Unlimited

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

50 subjects will be identified during glaucoma clinic follow-up at Hong Kong Eye Hospital.

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-01-10

21 Target Sample Size

50

22 Recruitment Status

Complete

23 Primary Outcome

The primary outcome measures are IOP and the number of IOP-lowering drugs.

24 Secondary Outcome

Secondary outcome measures include BCVA, surgical complications, and need for additional surgical interventions.

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2018-04-20

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004233

28 Date of Registration in Primary Registry

Back History

Trial Detail