Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00511

2 Trial Registration Date

2016-05-09

i Registration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Glaukos Corporation

5 Primary Sponsor

Glaukos Corporation

6 Secondary Sponsor

Nil

Function

Not Applicable

Please specify

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

i Name

Dickson Lo

ii Address

3/F, Hong Kong Eye Hospital
147K Argyle Street, Mongkok,
Kowloon, Hong Kong

iii Phone

39435813

iv Email

Dicksonlo@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Dr. Leung Kai Shun Christopher

ii Address

3/F, Hong Kong Eye Hospital
147K Argyle Street, Mongkok,
Kowloon, Hong Kong

iii Phone

Tel: 2762 3080;

iv Email

cksleung@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

A pilot study evaluating the safety and efficacy of suprachoroidal stent implantation in eyes with primary angle closure

10 Public Title

A pilot study evaluating the safety and efficacy of suprachoroidal stent implantation in eyes with primary angle closure

i Public Title in Chinese 研究名稱

在原發性房角關閉的眼睛植入脈絡引流支架的安全性及有效性的試驗研究

11 Short Title (Optional)

iStent Study

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?

2016-04-29

iii Full Name of IRB/IEC

Kowloon Central Cluster REC / Kowloon East Cluster REC

Please specify

iv IRB/IEC approval reference number

KC/KE-16-0015/FR-3

14 Medical Condition Being Studied

Primary Angle Closure (PAC) and Primary Angle Closure Glaucoma (PACG)

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Investigating the IOP lowering effect and the safety profile iStent Supra implantation in Chinese eyes with PAC or PACG

iii Dosage form of the intervention

Nil

iv Dosage of the intervention

Nil

v Duration of the intervention

Twelve Months

vi Frequency of the intervention

Nil

16 Comparative Treatments

i Description/ name of comparative treatments

Nil

ii Dosage form of the comparative treatments

Nil

iii Dosage of the comparative treatments

Nil

iv Duration of the comparative treatments

Nil

v Frequency of the comparative treatments

Nil

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

PAC or PACT Chinese patients who are 18 years of age or above

The trabecular meshwork is not visible for more than 180° on dark room gonioscopy

IOP >22mmHg

Without secondary causes of angle closure identified. PACG is diagnosed in eyes with PAC with evidence of glaucomatous optic disc damage (i.e. narrowing of neuroretinal rim, thinning of retinal nerve fiber layer, optic disc excavation with or without corresponding visual field defects).

A clear view of the angle at the intended implantation site, via gonioscopy at the screening visit and again at the operative exam.

ii Exclusion Criteria

Peripheral anterior synechiae more than 180 degree at the nasal side

Visual acuity worse than 6/60, pseudophakic, phakic with cataractous lens expected to require cataract surgery within 12 months of the screening exam

The presence of advanced visual field defects with mean deviation (MD) <-18 dB

Chronic or recurrent uveitis

Pregnancy

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

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-05-11

21 Target Sample Size

30

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

IOP reduction from preoperative IOP at 12 months of follow-up.

ii The metric or method of measurement used

One iStent Supra will be implanted in each eligible eye by a single surgeon(CL). If both eyes are eligible, the eye with milder visual field damage will be included and the fellow eye will be managed at the discretion of the attending clinicians. IOP will be measured.

iii The timepoint(s) of primary interest

IOP will be measured at three different time points during the day (9am, 1pm, 5pm) at the baseline visit, and at 9 and 12 months following the surgery. Addiional IOP measurements are collected at 9am at 1day, 1week, 3 and 6 months.

24 Secondary Outcome

i The Name of the outcome

Investigate the side effect of iStent.

ii The metric or method of measurement used

Adverse effects are recorded during the follow-up.

iii The timepoint(s) of primary interest

During the follow-up visits.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-06-06

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2016-05-09