CCRB Logo

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

Myopic Glaucoma

Drug

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.

1. Prostaglandin Analogs (PGA) and or
2. Carbonic anhydrase inhibitors (CAI) and or
3. Bromide and or
4. Selective Laser Trabeculoplasty (SLT)

1. topical ; 2: topical ; 3: topical ; 4: laser

1 - 3: depending on the doctor's discretion; 4: 0.5mw - 1mw

1 - 4: 24 months

1 - 4: 2-month intervals

Non-progressors will be randomized in the same manner. Non-progressors are also randomized as they may develop VF progression indep endent of progressive RNFL thinning. If both eyes are eligible for study inclusion, both eyes will be randomized to additional or continued treatment (i.e. both eyes will be randomized to additional treatment even if only one eye is classified as progressor). Additional IOP-lowering treatment will not be given to any individuals in Phase I unless a study end-point is reached.

1. Prostaglandin Analogs (PGA) : Travian (0.002%) / Xalatan and or
2. Carbonic anhydrase inhibitors (CAI): Azopt / Trusopt

1 - 2 : topical

Travian (0.002%) once daily ; Xalatan once daily ; Azopt three times daily; Trusopt three times daily

1 - 2 : 24 months

1 - 2 : 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

Single-blind

Investigator/research team

Parallel

4

2018-04-02

203

Recruiting

The proportion of eyes with VF progression. We expect that the absolute risk reduction (ARR) of VF progression (i.e. the difference in the proportion of eyes with VF progression between the additional treatment and continued treatment arms) in progressors will be greater than that in non-progressors

The absolute risk reduction (ARR) of VF progression

24 months

The rate of change of VF mean deviation (MD)

The peak rate of RNFL thinning

24 months

No

2020-06-26

ChiCTR1800015147

2018-03-09

Type Document Published On  
No documents yet.
  • Page 1 of 1.