Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00407

2 Trial Registration Date

2014-04-17

iRegistration Status

Prospective

3 Secondary IDs

Nil

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

39435869

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. LEUNG Kai Shun Christopher

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

3943 5846

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 Randomized Controlled Trial Comparing the Efficacy and Safety between Pattern Laser Trabeculoplasty and Selective Laser Trabeculoplasty

10 Public Title

A Randomized Controlled Trial Comparing the Efficacy and Safety between Pattern Laser Trabeculoplasty and Selective Laser Trabeculoplasty

i Public Title in Chinese 研究名稱

模式化激光小梁成形術與選擇性激光小梁成形術療效及安全性的隨機對照試驗

11 Short Title (Optional)

PLT vs SLT

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-07-18

iii Full Name of IRB/IEC

Kowloon Central Cluster REC / Kowloon East Cluster REC

Please specify

iv IRB/IEC approval reference number

KC/KC-13-0096/FR-1

14 Medical Condition Being Studied

Glaucoma

15Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Patterned Laser Trabeculoplasty (PLT)
Selective Laser Trabeculoplasty (SLT)

iii Dosage form of the intervention

Laser

iv Dosage of the intervention

532nm

v Duration of the intervention

10 minutes

vi Frequency of the intervention

NA

16Comparative Treatments

i Description/ name of comparative treatments

Regarding selective laser trabeculoplasty (SLT), a drop of Brimonidine will be instilled into the eye to be treated 15 minutes prior to the procedure. Topical anaesthesia will be administered and the Latina SLT lens and coupling fluid will be used for the procedure. The slit-lamp attached to the laser will be focused on the full height of the trabecular meshwork. The laser power will be set to 0.6mJ and increased in 0.1mJ steps until small champagne –like bubbles appear from the treated area of the trabecular meshwork.Approximately 50-60 non-overlapping shots will be placed onto at least 180 degrees of the trabecular meshwork that is visible and without PAS. More non-overlapping shots can be placed if sufficient extent of the trabeculum is visible.A second laser treatment targeting the same previously treated area of the meshwork can be done at the 1 or 4 week follow up visit if the IOP returns to pretreatment levels.

Patterned laser trabeculoplasty has a therapeutic wavelength of 532nm and a spot size of 100 µm. Power is titrated using a single spot to achieve light trabecular meshwork blanching with 10-ms laser pulses in the inferior segment of the eye. After titration the power is maintained but the pulse duration is reduced to 5ms, and a predetermined pattern of laser spots are used. Laser beams are directed on the trabecular meshwork for 180-360 degrees. The total duration of laser treatment is approximately 10 minutes.

ii Dosage form of the comparative treatments

Laser

iii Dosage of the comparative treatments

0.6mj

iv Duration of the comparative treatments

10 minutes

v Frequency of the comparative treatments

NA

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

-A diagnosis of POAG or OHT
-Older than 18 years of age
-Able to give informed consent

ii Exclusion Criteria

-Significant cataract rendering visual field testing or optic disc imaging not technically possible
-Previous SLT or ALT
-Previous glaucoma surgery
-Participation in another therapeutic drug study within the last 30 days
-Severe health problems precluding follow-up such as end-stage heart disease, kidney disease, respiratory disease, or cancer.
-Patients using systemic steroids

iii Age Minimum

Older than 18 years of age

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

Patient will be randomized for Patterned Laser Trabeculoplasty or Selective Laser Trabeculoplasty

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-05-01

21 Target Sample Size

132

22 Recruitment Status

Recruiting

23 Primary Outcome

Intraocular pressure will be measured with Goldmann applanation tonometry at baseline, 1 week, 1 month, 3 months and 6 months, 9 months and 1 year after PLT or SLT treatment.

24 Secondary Outcome

The density of cataract will be assessed with the Lens Opacity Classification System III (LOCS III) with standard color photographs as the reference for grading of lens opacity. Progression in lens opacity was defined as an increase in LOCS III grade by 2 or more units in any lens region.

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2019-07-30

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004521

28 Date of Registration in Primary Registry

2014-04-17

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Trial History Detail on 2016-04-08