Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00329

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

Not Applicable

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

Hong Kong

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

Hong Kong

9 Official Scientific Title of the Study

Prospective contralateral eye comparison of different LASIK flap thickness

10 Public Title

Prospective contralateral eye comparison of different LASIK flap thickness

i Public Title in Chinese 研究名稱

比較雙眼對側於不同准分子激光膜原位磨鑲手術角膜瓣厚度的前瞻性研究

11 Short Title (Optional)

Contralateral eye comparison of different LASIK flap thickness

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?

2012-03-05

iii Full Name of IRB/IEC

Kowloon Central Cluster REC / Kowloon East Cluster REC

Please specify

iv IRB/IEC approval reference number

KC/KE 12-0030/ER-1

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

LASIK

iv Dosage of the intervention

A flap 120 microns thick

v Duration of the intervention

Once

vi Frequency of the intervention

Once

16 Comparative Treatments

i Description/ name of comparative treatments

LASIK would be performed in both eyes of a suitable patient. One eye shall receive a flap cut of 100 microns and the contralateral eye shall receive a flap cut of 120 microns.

ii Dosage form of the comparative treatments

LASIK

iii Dosage of the comparative treatments

LASIK with a flap 120 microns thick

iv Duration of the comparative treatments

Once

v Frequency of the comparative treatments

Once

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1.Any person greater than 18 years of age, requiring LASIK for refractive errors correction under topical anesthesia.
2.Willing to participate and give a consent after full explanation of the aims, risks and benefits of the study

ii Exclusion Criteria

1.Patients with other ocular or systemic conditions.
2.Patients not cooperative or patient with conditions that prevent them to cooperate to undergo the LASIK procedure under topical anesthesia by gel / eye drops
3.Patients < 18 years of age
4.Patients who are unable to sign the consent

iii Age Minimum

18

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

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2012-05-01

21 Target Sample Size

150

22 Recruitment Status

Complete

23 Primary Outcome

Visual acuity: uncorrected and best-corrected at day 1, day 3, month 1, month 3; Postoperative spherical equivalent at day 1, day 3, month 1, month 3

24 Secondary Outcome

Corneal haze, Dry eye syndrome, Anetrior segment OCT and Ocular response analyzer at day 1, day 3, month 1, month 3

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

Back History

Trial Detail