Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00328

2 Trial Registration Date

2012-07-30

i Registration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Nil

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Ms. Joyce Kung

ii Address

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

iii Phone

27623134

iv Email

joycekung@cuhk.edu.hk

v Affiliation

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

vi Country

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

i Name

Dr. Vishal Jhanji

ii Address

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

iii Phone

3943 5807

iv Email

vishaljhanji@cuhk.edu.hk

v Affiliation

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

vi Country

9 Official Scientific Title of the Study

Comparative Evaluation of Side Cut Angles during Femtosecond LASIK

10 Public Title

Comparative Evaluation of Side Cut Angles during Femtosecond LASIK

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Side Cut Angles during Femtosecond 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?

2011-09-08

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

Procedure

Please specify

ii Description/ name of Intervention/article

LASIK (Laser in situ Keratomileusis)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Once

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

LASIK would be performed in both eyes of a suitable patient using the femtosecond technology in a standard manner. One eye would receive a flap cut with 115 degrees of side cut and the fellow eye would receive a LASIK flap with side cut angle of 70 degrees. Both eyes would be operated in the same sitting.

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

•Patients intending to receive bilateral LASIK;
•Age of >21 years;
•Myopic refractive error
•Informed consent

ii Exclusion Criteria

1. Patients who are found to be unsuitable for inverse cut angle
2. Patients contraindicated for refractive surgery;
3. Pre-existing corneal haze;
4. Patients unable to complete the follow-up

iii Age Minimum

21

iv Age Maximum

Nil

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2011-09-30

21 Target Sample Size

50

22 Recruitment Status

Suspended

23 Primary Outcome

UCVA, BCVA, Corneal hysteresis, Flap size at Baseline, 1 week, 1 month and 3 months

24 Secondary Outcome

Flap thickness at 1 week; Corneal thickness at 1 month and 3 months

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-13

27 Primary Registry and Trial Identifying Number

ChiCTR-ONRC-12002391

28 Date of Registration in Primary Registry

2012-08-05

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2012-12-07