Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00419

2 Trial Registration Date

2014-06-24

i Registration Status

Prospective

3 Secondary IDs

CREC 2014.283-T

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

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Ms Janice Wong

ii Address

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

iii Phone

39435825

iv Email

janicewong@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr. Jhanji, Vishal

ii Address

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

iii Phone

39435807

iv Email

vishaljhanji@cuhk.edu.hk

v Affiliation

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

vi Country

9 Official Scientific Title of the Study

Randomized, Contralateral Eye Study to Evaluate the Safety and Efficacy of anti-glaucoma treatment for prevention of regression after Myopic LASIK

10 Public Title

Randomized, Contralateral Eye Study to Evaluate the Safety and Efficacy of anti-glaucoma treatment for prevention of regression after Myopic LASIK

i Public Title in Chinese 研究名稱

青光眼藥物治療用於控制近視LASIK術後回退的功效及安全性隨機對照臨床試驗

11 Short Title (Optional)

Safety and Efficacy of anti-glaucoma treatment for prevention of regression after Myopic LASIK

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?

2014-06-13

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Refractive error

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Timolol

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Twice daily

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

One eye of each patient would receive preservative free timolol 0.5% eye drops twice daily in one randomly chosen eye. Treatment would be started at 1 week after surgery and would be continued up to 3 months postoperatively.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Patients with myopia or myopic astigmatism aged 21 years or more
2. Anisometropia < 1 diopter

ii Exclusion Criteria

1. Patients aged < 21 years
2. Patients in which the target refraction is not emmetropia
3. Patients with ocular inflammation, diabetes mellitus, connective tissue disorders
4. Patients who have used retinoid acid or equivalent in the past 6 months

iii Age Minimum

21 years old

iv Age Maximum

999 years old

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-07-09

21 Target Sample Size

87

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

1. Spherical equivalent
2. Uncorrected visual acuity (UCVA)

24 Secondary Outcome

1. Change in corneal curvature as observed on the corneal topography
2. Change in corneal thickness on corneal topography
3. Adverse effects associated with the treatment

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-08

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004839

28 Date of Registration in Primary Registry

2014-06-24

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2014-07-07