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Trial History Detail on 2018-11-15

CUHK_CCT00407

2014-04-17

Prospective

Nil

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

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

Nil

Not Applicable

Ms. Jennifer Tsoi

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

39435869

jennifertsoi@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

Prof. LEUNG Kai Shun Christopher

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

3943 5846

cksleung@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

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

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

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

PLT vs SLT

Hong Kong

Yes

2013-07-18

Kowloon Central Cluster REC / Kowloon East Cluster REC

KC/KC-13-0096/FR-1

Glaucoma

Procedure

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

Laser

532nm

10 minutes

NA

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.

Laser

0.6mj

10 minutes

NA

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

-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

Older than 18 years of age

999

Both Male and Female

Interventional

Randomized

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

Active

Single-blind

Trial subjects

Parallel

4

2014-05-01

132

Complete

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

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.

No

2019-07-30

ChiCTR-TRC-14004521

2014-04-17

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