Femto LDV Z8
DeviceFemtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification
Other names: Treatment A
NCT Number: NCT02351271
The aim of the study is to demonstrate the performance and safety of the Femtosecond laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV Z8 compared to conventional technique in cataract surgery.
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Notify Me50 year and older
All sexes
Interventional
Not applicable
Cataract Surgery according to conventional procedure, with the exception of two steps (Capsulotomy and Lens Fragmentation) which are performed with a Femtosecond Laser in the study group. Used equipment for measurements is the same for both groups and in line with the normal equipment used for the conventional cataract treatment (group A) Cataract surgery will be performed conventionally, this means the capsulorhexis will be performed manually by a hook, and the lens extraction will be done by phacoemulsification. (group B)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification
Other names: Treatment A
Control treatment where the capsulorhexis is performed manually and the lens fragmentation is performed by the stop and chop technique with the phaco emulsification device
Other names: Treatment B
Time frame: day of surgery
Effective Phacoemulsification Time (EPT): EPT for eyes receiving Intervention A being statistically same or lower than EPT for eyes receiving Intervention B at p<0.05 will be considered positive for superior efficacy of application of FEMTO LDV Z8 over the manual procedure
Effective Phaco Time is a unit. It is commonly understood in the area of cataract surgery to be the standard way to describe phaco energy during a procedure over different manufactured phaco devices.
Effective phaco time is the total phaco time at 100 percent phaco power. It can be less than the total foot-pedal time. Less EPT indicates proportionately less energy delivered to the eye thereby reducing the side effects of phaco power.
Time frame: during surgery
Ease of phacoemulsification was performed as a subjective observation by the surgeon. Four classifications were possible: easy - phacoemulsification was fast and uncomplicated; 'slight resistance' - phacoemulsification encountered some difficulty; 'resistance noted' - phacoemulsification was somewhat complex; 'difficult' - phacoemulsification was difficult and complex to complete.
Time frame: during surgery
Completeness of capsulotomy is a subjective metric given by the surgeon. Measurements were scaled into the following four categories: 1: complete treatment pattern; 2: micro-adhesion; 3: incomplete treatment pattern; 4: complete pattern but not continuous. "Complete treatment pattern" is considered the best result, "micro adhesion" indicates a minor but manageable problem, "incomplete treatment pattern" indicates a treatable, but more complex suboptimal outcome and "complete treatment but discontinuous pattern" indicates the treatable but suboptimal outcome.
Time frame: during follow-up after 1 and 12 days, 4, 8 and 12 weeks
Safety will be assessed by evaluating observed and/or reported device and non-device related Adverse Events and/or Adverse Device Effects between treatment intervention groups A and B. No serious adverse events were reported. One AE in the femto group and two in the manual group were reported.
Ziemer Ophthalmic Systems AG
Industry
A Single Centre Randomized Eye Study to Compare the Performance and Safety of Femtosecond Laser-assisted Cataract Procedures With Conventional Ultrasound-assisted Cataract Surgery
Acronym: COMFORT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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