Clinical trial NCT03970525: Venturi and Peristaltic Based Phacoemulsification in Femtosecond Laser Cataract Surgery
Official title: A Comparison of Venturi and Peristaltic Based Phacoemulsification in Femtosecond Laser Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Senile
Lead sponsor: Mercy Research
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson Surgical Vision, Inc.
First posted: 2019-05-31
Enrollment: 111
Sex: ALL
Minimum age (years): 22
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Phacoemulsification energy required during femtosecond laser cataract surgery procedure
timeFrame: Intraoperative Visit
measure: Duration of ultrasound time required during femtosecond laser cataract surgery procedure
timeFrame: Intraoperative Visit
measure: Phacoemulsification power required during femtosecond laser cataract surgery procedure
timeFrame: Intraoperative Visit
measure: Duration of microscope time required during femtosecond laser cataract surgery procedure
timeFrame: Intraoperative Visit
measure: Duration of laser time required during femtosecond laser cataract surgery procedure
timeFrame: Intraoperative Visit
Secondary outcomes:
measure: Uncorrected visual acuity among subjects who underwent femtosecond laser cataract surgery procedure
timeFrame: 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: Best Corrected Visual Acuity among subjects who underwent femtosecond laser cataract surgery procedure
timeFrame: 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: Pinhole Visual Acuity among subjects who underwent femtosecond laser cataract surgery procedure
timeFrame: 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: Presence of corneal edema as assessed by intra-ocular pressure
timeFrame: 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: Presence of corneal edema as assessed by slit lamp examination
timeFrame: 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: Measure of the corneal endothelium
timeFrame: This test will be done Pre-operatively and Post op 60-90 day visit
measure: Central corneal thickness as measured by IOLMaster Biometry
timeFrame: 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: Central corneal thickness as measured by Galilei G4 Biometry
timeFrame: 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:
measure: Adverse Events
timeFrame: 90 days
Locations:
city: Springfield
country: United States
facility: Mercy Clinic Eye specialists
state: Missouri
Study officials:
affiliation: Mercy Hospital
name: Wendell J Scott, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Basic Principles of Phacoemulsification and Fluid Dynamics. Retrieved from https://www.aao.org/focalpointssnippetdetail.aspx?id=fde87039-2700-4d45-808a-9af6226a983d
citation: 5. Peristaltic and Venturi Fluid Pumps. Retrieved from https://www.aao.org/focalpointssnippetdetail.aspx?id=42e35231-7641-4190-b0cd-7ffdc1b8de74
citation: 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.
citation: 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.
citation: 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