AzTrials
AzTrials

Cataract SenileNCT03970525

Venturi and Peristaltic Based Phacoemulsification in Femtosecond Laser Cataract Surgery

An observational study of Cataract Senile, run by Wendell Scott at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 22 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Cataract Senile
What is being tested?
Venturi pump and Peristaltic vacuum pump
Type of treatment
Medical device
How many people
111 participants
Where
1 siteUnited States
Study dates
16 May 2019to 29 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • History of previous eye surgery
  • Severe glaucoma or retina disease impairing vision
  • Planned surgery that is will be combined with other surgical eye procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mercy Clinic Eye specialists

    Springfield, Missouri, 65804

Other trials in United States

About this study

Official title: A Comparison of Venturi and Peristaltic Based Phacoemulsification in Femtosecond Laser Cataract Surgery

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.

Read the detailed description

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:
  • For Venturi pump: 600 mmHg vacuum
  • For Peristaltic-based pump: 600 mmHg vacuum and aspiration flow of 50 mL/min
  • Other settings: ultrasound energy application parameters will be the same for the two groups

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:
  • Nidek Refractive Power/Corneal Analyzer OPD-Scan, Galilei G4 Corneal Topography, IOLMaster 700 keratometry (standard of care)
  • Complete eye examination (standard of care)
  • Brightness Acuity Test (BAT) (standard of care)
  • Review and confirm eligibility (research)
  • Informed Consent for study (research)
  • Randomization (research)
  • Endothelial Cell Count (research)
  • Medical Record Review (research)
  • Surgical Procedure (Day 0) (standard of care)
  • Medical Record Review (research)
  • Adverse Event Assessment (research)
  • Post-operative Visit 1 (Day 1):
  • Eye exam to include uncorrected and pinhole visual acuity, Intraocular pressure (IOP) and slit-lamp exam (standard of care)
  • Galilei G4 Corneal Topography, IOLMaster 700 keratometry (standard of care)
  • Medical Record Review (research)
  • Adverse Event Assessment (research)
  • Post-operative Visit 2 (Day 5-10):
  • Eye exam to include uncorrected and best corrected visual acuity, Pinhole visual acuity, IOP, and slit-lamp exam (standard of care)
  • Nidek Refractive Power/Corneal Analyzer OPD-Scan, Galilei G4 Corneal Topography, IOLMaster 700 keratometry (standard of care)
  • Medical Record Review (research)
  • Adverse Event Assessment (research)
  • Post-operative Visit 3 (Day 60-90 days):
  • Eye exam to include uncorrected and best corrected visual acuity, Pinhole visual acuity, IOP, and slit-lamp exam (research)
  • Nidek Refractive Power/Corneal Analyzer OPD-Scan, Galilei G4 Corneal Topography, IOLMaster 700 keratometry (research)
  • Endothelial Cell Count (research)
  • Medical Record Review (research)
  • Adverse Event Assessment (research)
  • Unscheduled Visit:
  • A medical record review and an adverse event assessment will be performed at any unscheduled visit.
  • Additional evaluations will be completed at the discretion of the Principal Investigator based on the subject's presenting complaint.

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.
Conditions
Cataract Senile
Being tested
Venturi pump, Peristaltic vacuum pump

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Venturi pumpDevice

    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.

  • Peristaltic vacuum pumpDevice

    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.

Study groups in NCT03970525
Study groupRoleWhat they receive
Venturi pumpThis cohort will receive femtosecond laser cataract surgery with Venturi pump.
Receives: Device: Venturi pump
Peristaltic vacuum pumpThis cohort will receive femtosecond laser cataract surgery with peristaltic pump.
Receives: Device: Peristaltic vacuum pump

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.)

    Measured: Intraoperative Visit

  2. Duration of ultrasound time required during femtosecond laser cataract surgery procedure

    Total ultrasound time - measured in seconds

    Measured: Intraoperative Visit

  3. Phacoemulsification power required during femtosecond laser cataract surgery procedure

    Average power - measured in percentage

    Measured: Intraoperative Visit

  4. Duration of microscope time required during femtosecond laser cataract surgery procedure

    Microscope time - measured in seconds intraoperatively

    Measured: Intraoperative Visit

  5. Duration of laser time required during femtosecond laser cataract surgery procedure

    Laser time - measured in seconds intraoperatively

    Measured: Intraoperative Visit

Secondary outcomes (8)

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

    1. Uncorrected Visual Acuity using the Snellen Eye Chart

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

  2. Best Corrected Visual Acuity among subjects who underwent femtosecond laser cataract surgery procedure

    Best Corrected Visual Acuity using the Snellen Eye Chart

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

  3. Pinhole Visual Acuity among subjects who underwent femtosecond laser cataract surgery procedure

    Pinhole visual acuity using pinhole technique and the Snellen eye chart

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

  4. Presence of corneal edema as assessed by intra-ocular pressure

    Measured in mmHg using an applanation tonometer

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

  5. 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

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

  6. Measure of the corneal endothelium

    Endothelial Cell Count will be evaluated by Konan Specular Microscopy

    Measured: This test will be done Pre-operatively and Post op 60-90 day visit

  7. Central corneal thickness as measured by IOLMaster Biometry

    IOL Master Biometry directly measures the corneal thickness by OCT

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

  8. Central corneal thickness as measured by Galilei G4 Biometry

    Galilei G4 measures central corneal thickness

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2019
  2. Study start16 May 2019
  3. Primary completion16 Mar 2023
  4. Study completion29 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03970525
Sponsor's protocol ID
19-082
Status last verified
Mar 2023
First submitted
24 May 2019
Last updated
3 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 29970039

  • 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.

    PubMed 29455164

  • Basic Principles of Phacoemulsification and Fluid Dynamics. Retrieved from https://www.aao.org/focalpointssnippetdetail.aspx?id=fde87039-2700-4d45-808a-9af6226a983d

  • 5. Peristaltic and Venturi Fluid Pumps. Retrieved from https://www.aao.org/focalpointssnippetdetail.aspx?id=42e35231-7641-4190-b0cd-7ffdc1b8de74

  • 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.

    PubMed 22624907

  • 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.

    PubMed 23231739

  • 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

  • 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.

    PubMed 39853262

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract Senile, run by Wendell Scott at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phacoemulsification energy required during femtosecond laser cataract surgery procedure (time frame: Intraoperative Visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03970525, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in