Safety and Efficacy of FLACS With the FEMTO LDV Z8 Laser Compared to Conventional Cataract Surgery in Chinese Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of FLACS With the FEMTO LDV Z8 Laser Compared to Conventional Cataract Surgery in Chinese Patients

Conditions
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Cataract

Intervention / Treatment
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* Device: Femtosecond Laser Assissted Cataract Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLACS Group<br>Femto Laser treated (anterior Capsulotomy and Fragmentation of lens body before phaco emulification) | Device: Femtosecond Laser Assissted Cataract Surgery<br>* During routine Catarct Surgery the Femtolaser cuts a ACCC (Anterior Continous Curvilinear Capsulotomy) into the lensbag and fragmentise the cataract affilited lens body<br>|
| Active Comparator: Manual Group<br>Gold Standard Method with manual rhexis with pinzette and phaco emulsification | Device: Femtosecond Laser Assissted Cataract Surgery<br>* During routine Catarct Surgery the Femtolaser cuts a ACCC (Anterior Continous Curvilinear Capsulotomy) into the lensbag and fragmentise the cataract affilited lens body<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell loss | To determine whether the FLACS with the FEMTO LDV Z8 laser is non-inferior to measured using the NSP 9900, KONAN MEDICAL, and calculated according to: postoperative endothelial cell loss = preoperative endothelial count - postoperative endothelial cell count | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra- and post- surgical complications | Diagnosis of Complications in combination with usual follow-up measures | 4 month | 
| Cumulative dissipated energy (CDE) | Recording of CDE on Phaco device | 4 month | 
| Ultrasound (US) total time | Record of US Energy applied | 4 month | 
| Estimated fluid usage (EFU) | Record of EFU | 4 month | 
| Corneal thickness (CCT) | Mesurement of the Central Corneal Thickness | 4 month | 
| Uncorrected distance visual acuity (UDVA) | Measurement of UDVA | 4 month | 
| Corrected distance visual acuity (CDVA) | Measurement of CDVA | 4 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femto Cataract Surgery