An interventional study of Femtosecond Laser Assissted Cataract Surgery in Cataract, sponsored by Ziemer Ophthalmic Systems AG. Completed at 1 site in Switzerland. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-12-27.
Sponsored by Ziemer Ophthalmic Systems AG · Not applicable, Interventional, and Treatment
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 132 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Ziemer Ophthalmic Systems AG is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Femto Laser treated (anterior Capsulotomy and Fragmentation of lens body before phaco emulification)
Device: Femtosecond Laser Assissted Cataract Surgery
Gold Standard Method with manual rhexis with pinzette and phaco emulsification
Device: Femtosecond Laser Assissted Cataract Surgery
During routine Catarct Surgery the Femtolaser cuts a ACCC (Anterior Continous Curvilinear Capsulotomy) into the lensbag and fragmentise the cataract affilited lens body
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
Time frame: 4 month
Intra- and post- surgical complications
Diagnosis of Complications in combination with usual follow-up measures
Time frame: 4 month
Cumulative dissipated energy (CDE)
Recording of CDE on Phaco device
Time frame: 4 month
Ultrasound (US) total time
Record of US Energy applied
Time frame: 4 month
Estimated fluid usage (EFU)
Record of EFU
Time frame: 4 month
Corneal thickness (CCT)
Mesurement of the Central Corneal Thickness
Time frame: 4 month
Uncorrected distance visual acuity (UDVA)
Measurement of UDVA
Time frame: 4 month
Corrected distance visual acuity (CDVA)
Measurement of CDVA
Time frame: 4 month
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ziemer Ophthalmic Systems AG