Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00557

2 Trial Registration Date

2017-06-05

i Registration Status

Prospective

3 Secondary IDs

CREC Ref No: 2017.082

4 Source(s) of Funding

NA

5 Primary Sponsor

NA

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

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

i Name

Winnie Lee

ii Address

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, 3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

iii Phone

39430790

iv Email

winsze@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong, China

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

i Name

Dr Marten BRELEN

ii Address

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, 4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

iii Phone

39435846

iv Email

marten.brelen@cuhk.edu.hk

v Affiliation

Department of Ophthalmology and Visual Sciences

vi Country

Hong Kong, China

9 Official Scientific Title of the Study

Outcomes following Artisan iris claw versus scleral-fixated intraocular lens implantation

10 Public Title

Outcomes following Artisan iris claw versus scleral-fixated intraocular lens implantation

i Public Title in Chinese 研究名稱

Artisan虹膜夾持型人工晶體植入術與鞏膜固定型人工晶體植入術的療效對比

11 Short Title (Optional)

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?

2017-03-28

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC ref no. 2017.082

14 Medical Condition Being Studied

aphakia

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Artisan aphakia intraocular lens implant

iii Dosage form of the intervention

One intraocular lens per patient recruited into study

iv Dosage of the intervention

No dosage as this is a medical device not a drug

v Duration of the intervention

Intraocular lens remains inside eye indefinitely unless (due to complications) lens need replacing

vi Frequency of the intervention

A single surgical procedure

16 Comparative Treatments

i Description/ name of comparative treatments

Scleral fixation aims to fixate the IOL in the physiological location despite of a more skill demanding procedure. Iris fixation using claw shaped haptics attached to the mid-peripheral iris allows easy and fast IOL placement through the original main phacoemulsification incision.

ii Dosage form of the comparative treatments

Other commonly used intraocular lenses work in a similar manner. A single surgical procedure is used to implant the lens which remains inside the eye indefinitely.

iii Dosage of the comparative treatments

A single intraocular lens implanted per eye.

iv Duration of the comparative treatments

The lens implant remains inside the eye indefinitely

v Frequency of the comparative treatments

A single surgical procedure is performed to implant the intraocular lens

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Subjects with complicated phacoemulsification with adequate capsular support

2. No retained lens matter in vitreous cavity

3. Planned phacoemulsification

4. Planned secondary IOL implantation with or without vitrectomy from anterior approach for secondary cases

5. No other ocular comorbidities except cataract

6. Participants who can give consent and aged 18 or above

ii Exclusion Criteria

1. Combined cataract surgery with other ocular procedures including glaucoma or vitreoretinal operations

2. Significant retained lens matter requiring pars plana vitrectomy

3. History of ocular comorbidity

4. History of ocular surgery apart from cataract operation

5. Fail or refuse to give consent

iii Age Minimum

18

iv Age Maximum

999

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

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

NA

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-06-12

21 Target Sample Size

40

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Visual and Refractive Outcomes

ii The metric or method of measurement used

Visual acuity

iii The timepoint(s) of primary interest

The patients will be seen 1day, 1Week, 1month, 3months, 6months, 9months and 12months after surgery during the study

24 Secondary Outcome

i The Name of the outcome

Complications and change in corneal endothelial cell density are the secondary outcome.

ii The metric or method of measurement used

Secondary outcome measures for this study include refraction, endothelial cell count, corneal topography and slit lamp examination

iii The timepoint(s) of primary interest

The patients will be seen 1day, 1Week, 1month, 3months, 6months, 9months and 12months after surgery during the study

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-06-28

27 Primary Registry and Trial Identifying Number

ChiCTR-OON-17011613

28 Date of Registration in Primary Registry

2017-06-05

Back History

Trial Detail