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| Name | Class |
|---|---|
| Johnson & Johnson Surgical Vision, Inc. | INDUSTRY |
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This study will compare two methods of vacuum (peristaltic or venturi) commonly used during the removal of a femtosecond treated cataract. The investigators will observe which method uses less energy, is gentler on the eye, reduces corneal swelling and if the vision recovers faster with one method compared to the other.
This is an open, prospective, randomized study to evaluate efficiency and outcomes of femtosecond laser cataract surgery with phacoemulsification performed with one of two standard vacuum systems.
It is estimated that the duration of study participation will be up to 24 months.
There will be randomization to 1 of 2 groups. Both eyes of each subject will be enrolled in the study. The first eye will be randomized to either the Venturi or peristaltic-based vacuum pump. The second eye will then receive the other type of vacuum pump for that procedure.
Study Phases:
Pre-operative Visit Procedure Post-operative Follow up The subject will be seen 1 day, 5-10 days, and 90 days following the procedure.
Surgical Procedure
The cataract removal procedure will be performed under sterile technique and according to standard procedures. The femtosecond laser treatment will be followed by phacoemulsification removal of the cataract and implantation of an intraocular lens.
Peri-operatively, subjects will be treated with a regimen of antibiotic, steroid and nonsteroidal anti-inflammatory eye drops per standard of care.
All surgeries will be performed by the same experienced surgeon/principal investigator using the Catalys® SYSTEM femtosecond laser platform and WHITESTAR SIGNATURE® PRO Phacoemulsification System.
Phacoemulsification Settings:
Study Procedures
The study will include routine cataract pre-operative testing with Nidek OPD, Galilei G4, and IOLMaster, and repeated at the post-op visits. An endothelial cell count of the cornea will be performed at the pre-operative visit and at the 90 day follow up visit.
Subjects will be randomized to phacoemulsification settings of Venturi vacuum of 600 mmHg or peristaltic vacuum of 600 mmHg and aspiration flow of 50 mL/min. All other phacoemulsification settings will be identical. The laser settings will be based on the grade of cataract only and will not be altered for this study.
The phacoemulsification time, energy Ellips FX EFX, and average phacoemulsification energy will be recorded. The laser procedure time and total procedure time will be recorded. Complications will be recorded. Additional patient characteristics will also be recorded.
Pre-Operative Visit:
Surgical Procedure (Day 0) (standard of care)
Post-operative Visit 1 (Day 1):
Post-operative Visit 2 (Day 5-10):
Post-operative Visit 3 (Day 60-90 days):
Unscheduled Visit:
Statistical Analysis
Sample Size and Power:
· The study aims to enroll 250 study subjects for a total of 500 eyes with bilateral grade 1-3 nuclear sclerotic cataracts who will be undergoing planned femtosecond laser cataract surgery.
Statistical Methods:
· The statistical analysis plan will include use of descriptive statistics and statistical tests including unpaired t-tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venturi pump | This cohort will receive femtosecond laser cataract surgery with Venturi pump. |
| |
| Peristaltic vacuum pump | This cohort will receive femtosecond laser cataract surgery with peristaltic pump. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venturi pump | Device | The venturi pump makes use of the venturi effect to create a vacuum. The venturi effect creates a vacuum by the flow of a fluid, typically air, over an opening. In many phacoemulsification machines, this requires nitrogen tanks or a self-contained air compressor. The vacuum level is created within a rigid drainage cassette, to which the phaco aspiration tubing is connected. Since there is no milking of the aspiration line, the phaco tubing can be made rigid with low compliance. |
| Measure | Description | Time Frame |
|---|---|---|
| Phacoemulsification energy required during femtosecond laser cataract surgery procedure | Phaco EFX (the effective phaco time with a specific coefficient for the transversal movement of the phaco tip- expressed in seconds.) | Intraoperative Visit |
| Duration of ultrasound time required during femtosecond laser cataract surgery procedure | Total ultrasound time - measured in seconds | Intraoperative Visit |
| Phacoemulsification power required during femtosecond laser cataract surgery procedure | Average power - measured in percentage | Intraoperative Visit |
| Duration of microscope time required during femtosecond laser cataract surgery procedure | Microscope time - measured in seconds intraoperatively | Intraoperative Visit |
| Duration of laser time required during femtosecond laser cataract surgery procedure | Laser time - measured in seconds intraoperatively | Intraoperative Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected visual acuity among subjects who underwent femtosecond laser cataract surgery procedure | 1) Uncorrected Visual Acuity using the Snellen Eye Chart | This test will be done Pre-operatively and at Post op day 1, Post op day 5-10, and Post op day 60-90 |
| Best Corrected Visual Acuity among subjects who underwent femtosecond laser cataract surgery procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse Events will be recorded an monitored for each group and compared. | 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendell J Scott, MD | Mercy Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Clinic Eye specialists | Springfield | Missouri | 65804 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29970039 | Background | Wang J, Zhao J, Xu J, Zhang J. Evaluation of the effectiveness of combined femtosecond laser-assisted cataract surgery and femtosecond laser astigmatic keratotomy in improving post-operative visual outcomes. BMC Ophthalmol. 2018 Jul 3;18(1):161. doi: 10.1186/s12886-018-0823-1. | |
| 29455164 | Background | Day AC, Smith PR, Tang HL, Aiello F, Hussain B, Maurino V, Marshall J, Saleh GM. Surgical efficiency in femtosecond laser cataract surgery compared with phacoemulsification cataract surgery: a case-control study. BMJ Open. 2018 Feb 17;8(2):e018478. doi: 10.1136/bmjopen-2017-018478. |
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| Peristaltic vacuum pump | Device | The peristaltic pump uses rollers to compress the phacoemulsification outflow tubing in a peristaltic manner, thereby creating flow and vacuum. The compression of the rollers on the tubing with the rotation of the pump physically moves fluid and creates a continuous "milking" action on the fluid column, The phaco machine can directly control this flow level, hence the term flow based, however, the preset vacuum level is only achieved once there is occlusion of the outflow line, typically at the phaco needle tip with cataract material. |
|
Best Corrected Visual Acuity using the Snellen Eye Chart |
| This test will be done Pre-operatively and at Post op day 1, Post op day 5-10, and Post op day 60-90 |
| Pinhole Visual Acuity among subjects who underwent femtosecond laser cataract surgery procedure | Pinhole visual acuity using pinhole technique and the Snellen eye chart | This test will be done Pre-operatively and at Post op day 1, Post op day 5-10, and Post op day 60-90 |
| Presence of corneal edema as assessed by intra-ocular pressure | Measured in mmHg using an applanation tonometer | This test will be done Pre-operatively and at Post op day 1, Post op day 5-10, and Post op day 60-90 |
| Presence of corneal edema as assessed by slit lamp examination | The examiner will use a slit lamp microscope to evaluate the eye structures and intra-ocular pressure | This test will be done Pre-operatively and at Post op day 1, Post op day 5-10, and Post op day 60-90 |
| Measure of the corneal endothelium | Endothelial Cell Count will be evaluated by Konan Specular Microscopy | This test will be done Pre-operatively and Post op 60-90 day visit |
| Central corneal thickness as measured by IOLMaster Biometry | IOL Master Biometry directly measures the corneal thickness by OCT | This test will be done Pre-operatively and at Post op day 1, Post op day 5-10, and Post op day 60-90 |
| Central corneal thickness as measured by Galilei G4 Biometry | Galilei G4 measures central corneal thickness | This test will be done Pre-operatively and at Post op day 1, Post op day 5-10, and Post op day 60-90 |
| Background | Basic Principles of Phacoemulsification and Fluid Dynamics. Retrieved from https://www.aao.org/focalpointssnippetdetail.aspx?id=fde87039-2700-4d45-808a-9af6226a983d |
| Background | 5. Peristaltic and Venturi Fluid Pumps. Retrieved from https://www.aao.org/focalpointssnippetdetail.aspx?id=42e35231-7641-4190-b0cd-7ffdc1b8de74 |
| 22624907 | Background | DeMill DL, Zaugg BE, Pettey JH, Jensen JD, Jardine GJ, Wong G, Olson RJ. Objective comparison of 4 nonlongitudinal ultrasound modalities regarding efficiency and chatter. J Cataract Refract Surg. 2012 Jun;38(6):1065-71. doi: 10.1016/j.jcrs.2011.12.040. |
| 23231739 | Background | Conrad-Hengerer I, Hengerer FH, Schultz T, Dick HB. Effect of femtosecond laser fragmentation on effective phacoemulsification time in cataract surgery. J Refract Surg. 2012 Dec;28(12):879-83. doi: 10.3928/1081597X-20121116-02. |
| Result | 1. Jacobs, DS. (2019). Cataract in Adults. In T.W. Post, J. Trobe & J. Givens (Eds.), UpToDate. Available from https://www.uptodate.com/contents/cataract-in-adults?search=cataract&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1 |
| 39853262 | Derived | Scott RA, Holtmeyer CJ, Parker TM, Willis JK, Scott WJ, Olson RJ. Efficiency of venturi vs peristaltic-based phacoemulsification in femtosecond laser cataract surgery. J Cataract Refract Surg. 2025 May 1;51(5):382-387. doi: 10.1097/j.jcrs.0000000000001618. |