Venturi and Peristaltic Based Phacoemulsification in Femtosecond Laser Cataract Surgery

NCT03970525 | Completed FDA Device

• 1 other identifier: 19-082
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract Senile

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (8)

• Uncorrected visual acuity among subjects who underwent femtosecond laser cataract surgery procedure

  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

  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

  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

  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

  This test will be done Pre-operatively and at Post op day 1, Post op day 5-10, and Post op day 60-90

Other Outcomes (1)

• Adverse Events

  90 days

Study Arms (2)

Venturi pump

This cohort will receive femtosecond laser cataract surgery with Venturi pump.

Device: Venturi pump

Peristaltic vacuum pump

This cohort will receive femtosecond laser cataract surgery with peristaltic pump.

Device: Peristaltic vacuum pump

Interventions

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.

Venturi pump

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.

Peristaltic vacuum pump

Eligibility Criteria

• Age: 22 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* 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. * The study will include adults undergoing femtosecond laser cataract surgery with grade 1-3 nuclear sclerotic cataracts.

You may qualify if:

• Males and females ages 22-90 yrs
• Diagnosis of senile cataract
• Grade 1-3 Nuclear sclerosis
• Cataract removal required for both eyes
• Scheduled for femtosecond laser cataract surgery at Mercy Surgery Center or Mercy National Eye Center in Springfield, MO

You may not qualify if:

• Diagnosis of Fuch's dystrophy
• Presence of cornea scars
• Planned laser astigmatism treatment
• Diagnosis of pseudoexfoliation
• History of direct ocular trauma with secondary iris or lens trauma
• Presence of grade 4 cataracts
• History of previous eye surgery
• Severe glaucoma or retina disease impairing vision
• Planned surgery that is will be combined with other surgical eye procedures

Sponsors & Collaborators

• Wendell Scott: lead
• Johnson & Johnson Surgical Vision, Inc.: collaborator

Study Sites (1)

Mercy Clinic Eye specialists

Springfield, Missouri, 65804, United States

Location

Related Publications (8)

• 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.

  PMID: 29970039 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.

  PMID: 29455164 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

  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.

  PMID: 22624907 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.

  PMID: 23231739 BACKGROUND

• 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

  RESULT

• 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.

  PMID: 39853262 DERIVED

Study Officials

• Wendell J Scott, MD

  Mercy Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Ophthalmologist

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 31, 2019
• Study Start: May 16, 2019
• Primary Completion: March 16, 2023
• Study Completion: March 29, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)