Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00439

2 Trial Registration Date

2014-11-24

i Registration Status

Prospective

3 Secondary IDs

2014.532

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

7 Responsible 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

3943 5869

iv Email

jennifertsoi@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

Prof. Leung Christopher Kai Shun

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

39435846

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 control trial evaluating the efficacy of additional intraocular pressure lowering treatment upon detection of lamina cribrosa deformation

10 Public Title

A randomized control trial evaluating the efficacy of additional intraocular pressure lowering treatment upon detection of lamina cribrosa deformation

i Public Title in Chinese 研究名稱

一項旨在評估額外降低眼壓對具有篩板變形的青光眼治療有效性的隨機對照試驗

11 Short Title (Optional)

Nil

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?

2014-11-10

iii Full Name of IRB/IEC

Kowloon Central Cluster REC / Kowloon East Cluster REC

Please specify

iv IRB/IEC approval reference number

KC/KE-14-0198/FR-2

14 Medical Condition Being Studied

Glaucoma

15 Intervention

i Types of intervention

Other

Please specify

Drug and Procedure

ii Description/ name of Intervention/article

The intervention is to use additional eye drops and/or laser procedure to achieve 20% intraocular pressure (IOP) lowering from baseline.
Drug: prostaglandin analogue, brimonidine and carbonic anhydrase inhibitor
Procedure: Selective Laser Trabeculoplasty

iii Dosage form of the intervention

Eyedrop or laser procedure

iv Dosage of the intervention

every two months

v Duration of the intervention

Drug: prostaglandin analogue (PGA, once daily), brimonidine (three times daily), carbonic anhydrase

vi Frequency of the intervention

every two months

16 Comparative Treatments

i Description/ name of comparative treatments

The comparative treatment is to continue the current treatment (observation or one topical IOP lowering medication) started before recruitment (see Inclusion Criteria).

ii Dosage form of the comparative treatments

NA (depends on the current treatment)

iii Dosage of the comparative treatments

NA (depends on the current treatment)

iv Duration of the comparative treatments

every three months

v Frequency of the comparative treatments

NA (depends on the current treatment)

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1.Age ≥18 years
2.Best corrected visual acuity ≥ 20/40
3.POAG patients diagnosed within 12 months without prior history of glaucoma surgical/laser procedure and receiving not more than one topical IOP lowering medication

ii Exclusion Criteria

IOP >30mmHg measured at any time points during the screening visit; high myopia (spherical error<-6.0D); moderate and advanced VF loss (VF MD <-6dB in the worse eye) or defects close to fixation (any one of the paracentral points with sensitivity <10dB); inability to perform reliable VF; suboptimal quality of SDOCT images (see SDOCT imaging); previous intraocular surgery other than uncomplicated cataract extraction; and diabetic retinopathy/maculopathy.

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

100 patients

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

3

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-12-01

21 Target Sample Size

168

22 Recruitment Status

Recruiting

23 Primary Outcome

Proportion of eyes with VF progression

24 Secondary Outcome

Proportion of eyes with RNFL progression
Rate of change visual field index
Rate of change of LC deformation before and after IOP reduction
Risk factors of LC deformation

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-07-13

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-14005592

28 Date of Registration in Primary Registry

2014-12-03

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Trial History Detail on 2018-04-11