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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femto LDV Z8 | Experimental | Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification |
|
| Manual capsulorhexis&lens fragmentation | Active Comparator | The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femto LDV Z8 | Device | Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effective Phaco Time (EPT) | 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. | day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Phacoemulsification | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Reported Complications | 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. | during follow-up after 1 and 12 days, 4, 8 and 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bojan Pajic, MD, PhD | Augenzentrum ORASIS AG | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Femto LDV Z8 | Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification Femto LDV Z8: Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification 33 males (48.5%) and 35 females (51.5%) in the FLACS group |
| FG001 | Manual Capsulorhexis&Lens Fragmentation | The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification Manual capsulorhexis&lens fragmentation: 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 25 (40.3%) males and 37 females (59.7%) in the manual group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Femto LDV Z8 | Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification Femto LDV Z8: Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification 33 males (48.5%) and 35 females (51.5%) in the FLACS group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effective Phaco Time (EPT) | 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. | effective phaco time | Posted | Mean | Standard Deviation | EPT | day of surgery |
|
one year and 3 months
AE and SAE defined same as clinicaltrials.gov. As both interventions are limited to the anterior segment of the eye which is a contained anatomical space, deaths due to the intervention of either study group are considered to be zero. However, for the purpose of this study, all AE, SAE and deaths will be monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Femto LDV Z8 | Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification Femto LDV Z8: Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient IOP rise | Eye disorders | clinicaltrials.gov | Systematic Assessment | Intraocular pressure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Moyle | Ziemer Ophthalmic Systems AG | 970 308 9199 | sarah.moyle@ziemergroup.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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|
| Manual capsulorhexis&lens fragmentation | Device | 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 |
|
|
| during surgery |
| Number of Participants With Complete Treatment Pattern | 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. | during surgery |
| BG001 |
| Manual Capsulorhexis&Lens Fragmentation |
The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification Manual capsulorhexis&lens fragmentation: 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 25 (40.3%) males and 37 females (59.7%) in the manual group |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Manual Capsulorhexis&Lens Fragmentation | The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification Manual capsulorhexis&lens fragmentation: 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 25 (40.3%) males and 37 females (59.7%) in the manual group |
|
|
| Secondary | Ease of Phacoemulsification | 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. | Participants were classified as 'easy' or as 'slight resistance' in terms of ease of phacoemulsification. | Posted | Count of Participants | Participants | during surgery |
|
|
|
| Secondary | Number of Participants With Complete Treatment Pattern | 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. | In all cases, the capsulotomy was categorized as a complete treatment pattern | Posted | Count of Participants | Participants | during surgery |
|
|
|
| Other Pre-specified | Number of Participants With Reported Complications | 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. | Posted | Count of Participants | Participants | during follow-up after 1 and 12 days, 4, 8 and 12 weeks |
|
|
|
| 0 |
| 68 |
| 0 |
| 68 |
| 1 |
| 68 |
| EG001 | Manual Capsulorhexis&Lens Fragmentation | The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification Manual capsulorhexis&lens fragmentation: 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 | 0 | 62 | 0 | 62 | 2 | 62 |
|
| herpes zoster | Eye disorders | clinicaltrials.gov | Systematic Assessment |
|
| postoperative edema of the optic disk | Eye disorders | clinicaltrials.gov | Systematic Assessment |
|
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