Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00256

2 Trial Registration Date

2010-03-16

i Registration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Department Funding [Department of Ophthalmology & Visual Sciences]

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

Miss Joyce Kung

ii Address

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

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. Philip Lam

ii Address

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

iii Phone

27623134

iv Email

pthlam@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

Prospective randomized trial to evaluate the efficacy of topical Xylocaine gel versus Alcaine eye drops in the pain control in LASIK Surgery

10 Public Title

Prospective randomized trial to evaluate the efficacy of topical Xylocaine gel versus Alcaine eye drops in the pain control in LASIK Surgery

i Public Title in Chinese 研究名稱

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?

2006-11-25

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Myopia, corneal sensation

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Proparacaine and lidocaine (gel)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

2 mins

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Proparacaine and hydroxypropyl-methylcellulose (gel)

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.Any persons greater than 18 years of age, requiring LASIK for refractive errors correction under topical anesthesia who agrees to participate in the study and in whom pain scores can be reliably assessed.
2.Cooperative enough to receive LASIK under topical anesthesia by gel / eye drops
3.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, which are painful or require the regular use of analgesics.
2.Patients with medical, psychological and social conditions predisposing to a different perception of pain.
3.Patients who do not want to receive the gel during the LASIK procedure
4.Patients not cooperative or patient with conditions that prevent them to cooperate to undergo the LASIK procedure under topical anesthesia by gel / eye drops
5.Anisometropia > 1.5D

iii Age Minimum

Greater than 18 yr

iv Age Maximum

None set

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

Double-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

2007-06-04

21 Target Sample Size

70

22 Recruitment Status

Complete

23 Primary Outcome

Pain scores during application of anaesthesia, during the procedure (application of lid speculum, flap creation and laser application).

24 Secondary Outcome

Overall acceptance of the procedure
Complication related to pain or discomfort.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2012-04-18

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2010-03-23