Clinical trial NCT03953053: Safety and Efficacy of FLACS With the FEMTO LDV Z8 Laser Compared to Conventional Cataract Surgery in Chinese Patients
Official title: Safety and Efficacy of FLACS With the FEMTO LDV Z8 Laser Compared to Conventional Cataract Surgery in Chinese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Femto Cataract Surgery
Lead sponsor: Ziemer Ophthalmic Systems AG
Sponsor class: INDUSTRY
First posted: 2019-05-16
Enrollment: 132
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will be designed as a multi-center randomized non-inferiority clinical trial to demonstrate safety and efficacy of the FEMTO LDV Z8 laser for cataract surgery in a Chinese population in China compared to the conventional technique.

Detailed description: In this three center, prospective, interventional, randomized controlled study we aim to determine safety and efficacy of the FEMTO LDV Z8 laser as compared to conventional technique in Chinese patients diagnosed with cataract of any severity grade that are eligible to undergo cataract surgery with age 50 years and a maximum age of 80 years in China.

Eligibility criteria: Inclusion Criteria:

* Eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation
* Provision of signed and dated informed consent form
* Male or female, between 50 and 80 years of age (50 and 80 are included).
* IOL chosen for implantation a monofocal aspheric IOL of 6mm optic diameter
* Willing to comply with all study procedures and able to return for scheduled follow-up examinations
* Willing to adhere to the medication (to prevent inflammation and infection) regimen

Exclusion Criteria:

* Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
* Poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally (e.g., intraoperative floppy iris syndrome)
* Glaucoma or ocular hypertension, pseudoexfoliation
* Corneal endothelial pathology where endothelial cell count is compromised (Fuchs endothelial dystrophy and others)
* Complicated cataract, such as traumatic, white, intumescent or posterior and anterior subcapsular cataracts
* Nystagmus or hemofacial spasm preventing placement of the patient interface
* Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
* Allergy to medications required in surgery, pre- and post-operative treatment
* History of lens or zonular instability
* Keratoconus or keratectasia
* Immune compromised or diagnosis of ophthalmic disease: ocular herpes zoster or simplex, lupus, collagenosis and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study in the opinion of the study PI (Principal Investigator)
* Anterior chamber depth (ACD) \< 1.5 mm or \> 4.8 mm as measured from the corneal endothelium.
* Developmental disability or cognitive impairment that would make informed consent and the assessment of visual acuity impossible
* Concurrent participation in another ophthalmological clinical study

Primary outcomes:
measure: Endothelial cell loss
timeFrame: 4 month
Secondary outcomes:
measure: Intra- and post- surgical complications
timeFrame: 4 month
measure: Cumulative dissipated energy (CDE)
timeFrame: 4 month
measure: Ultrasound (US) total time
timeFrame: 4 month
measure: Estimated fluid usage (EFU)
timeFrame: 4 month
measure: Corneal thickness (CCT)
timeFrame: 4 month
measure: Uncorrected distance visual acuity (UDVA)
timeFrame: 4 month
measure: Corrected distance visual acuity (CDVA)
timeFrame: 4 month
Other outcomes:
Locations:
city: Port
country: Switzerland
facility: Ziemer Ophthalmic Systems AG
Study officials:
affiliation: The Eye Hospital of Wenzhou Medical University
name: A-Yong Yu, MD PHD Prof.
role: PRINCIPAL_INVESTIGATOR
References: