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Trial History Detail on 2017-07-03

CUHK_CCRB00557

2017-06-05

Prospective

CREC Ref No: 2017.082

NA

NA

NA

Not Applicable

Jimmy Lau

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

39435869

jimmylau@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong, China

Dr Marten BRELEN

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

39435846

marten.brelen@cuhk.edu.hk

Department of Ophthalmology and Visual Sciences

Hong Kong, China

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

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

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

Hong Kong

Yes

2017-03-28

Joint CUHK-NTEC Clinical Research Ethics Committee

CREC ref no. 2017.082

aphakia

Device

Artisan aphakia intraocular lens implant

One intraocular lens per patient recruited into study

No dosage as this is a medical device not a drug

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

A single surgical procedure

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.

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.

A single intraocular lens implanted per eye.

The lens implant remains inside the eye indefinitely

A single surgical procedure is performed to implant the intraocular lens

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

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

18

999

Both Male and Female

Interventional

Non-randomized

Active

Open label

Parallel

Other

NA

2017-06-12

40

Not Yet Recruiting

Visual and Refractive Outcomes

Visual acuity

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

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

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

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

No

2018-06-28

ChiCTR-OON-17011613

2017-06-05

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