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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLACS Group | Experimental | Femto Laser treated (anterior Capsulotomy and Fragmentation of lens body before phaco emulification) |
|
| Manual Group | Active Comparator | Gold Standard Method with manual rhexis with pinzette and phaco emulsification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femtosecond Laser Assissted Cataract Surgery | Device | During routine Catarct Surgery the Femtolaser cuts a ACCC (Anterior Continous Curvilinear Capsulotomy) into the lensbag and fragmentise the cataract affilited lens body |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A-Yong Yu, MD PHD Prof. | The Eye Hospital of Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziemer Ophthalmic Systems AG | Port | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37393278 | Derived | Zhou KJ, Huang Y, Wang Y, Pan AP, Shao X, Tu RX, Yu AY. Safety and efficacy of cataract surgery performed with a low-energy femtosecond laser compared with conventional phacoemulsification in Chinese patients: a randomized clinical trial. Eye Vis (Lond). 2023 Jul 2;10(1):31. doi: 10.1186/s40662-023-00347-0. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 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 |