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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
2018-06-28
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