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Trial Detail

CUHK_CCRB00591

2018-03-09

Prospective

KC/KE-16-0252/ER-1

Research Grants Council General Research Fund

Research Grants Council General Research Fund

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

Not Applicable

Jennifer Tsoi

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

39435818

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

39435803

cksleung@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

Measurement of the Rates of Retinal Nerve Fiber Layer Thinning to Guide Management of Myopic Glaucoma Patients

Measurement of the Rates of Retinal Nerve Fiber Layer Thinning to Guide Management of Myopic Glaucoma Patients

以測量視網膜神經纖維層變薄的速率去指引管理近視青光眼患者

Hong Kong

Yes

2017-02-06

Kowloon Central Cluster REC / Kowloon East Cluster REC

KC/KE-16-0252/ER-1

Glaucoma

Drug

Phase I - Patients will be randomized to receive a prostaglandin analogue (latanoprost) or a fixed-combination of alpha 2 agonist and carbonic anhydrase inhibitor (brinzolamide/brimonidine) after washout of topical IOP-lowering mediation (if any) for 4 weeks.

Phase II - Progressors identified in Phase I will be randomized (using computer generated random numbers) to an additional 20% IOP lowering from the baseline (i.e. mean IOP during follow-up in Phase I) or to continue existing treatment at 24 months. For patients randomized to receive additional IOP-lowering, latanoprost will be provided to those treated with brinzolamide/brimonidine in Phase I; brinzolamide/brimonidine will be provided to those treated with latanoprost in Phase I. If the target IOP cannot be attained with maximally tolerated medications, selective laser trabeculoplasty (SLT) will be performed.

Protocol amendment to include the randomization of latanoprost vs. brinzolamide/brimonidine in Phase I was approved by the Hong Kong Hospital Authority Research Ethnics Committee on 15 Feb 2018.

Topical medications; selective laser trabeculoplasty

0.005% latanoprost one drop daily; 1% brinzolamide 0.2% brimonidine twice; 360 degrees daily

Phase I - 24 months; Phase II - 12 months

2-month intervals

Phase I: latanoprost vs. brinzolamide/brimonidine
Phase II: progressors vs. non-progressors (i.e., eyes progressive RNFL thinning with vs. eyes without progressive RNFL thinning) for continue treatment vs. 20% additional IOP-lowering.

Topical medications; selective laser trabeculoplasty

0.005% latanoprost one drop daily; 1% brinzolamide 0.2% brimonidine twice daily; SLT - 360 degrees

Phase I - 24 months; Phase II - 12 months

2-month intervals

Primary open angle glaucoma patients (POAG) who are: age ≥18 years; best corrected VA ≥20/40; POAG diagnosed within 12 months at the time of recruitment and receiving not more than one IOP-lowering medication.

POAG with IOP>30mmHg; advanced VF loss (VF MD <-18dB in the worse eye) or defects close to fixation (any one of the paracentral points with sensitivity <10dB); pathological myopia (eyes with axial length≥26mm with lacquer cracks and chorioretinal atrophy); ocular or systemic diseases that may cause VF loss or optic disc abnormalities; inability to perform reliable VF; suboptimal quality of SDOCT images; previous intraocular surgery other than uncomplicated cataract extraction; and diabetic retinopathy/maculopathy.

18

999

Both Male and Female

Interventional

Randomized

Prospective study

Not Applicable

Open label

Parallel

4

2018-04-02

203

Suspended

Phase I: rate of change of RNFL thickness

Optical coherence tomography

24 months

Phase II: proportion of eyes with visual field progression

Standard automated perimetry

36 months

Rate of change of visual field mean deviation (MD)

Standard automated perimetry

24 and 36 months

Rate of change of change of RNFL thickness

Optical coherence tomography

36 months

No

2022-03-24

ChiCTR1800015147

2018-03-09

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