Phacoemulsification at High IOP and Physiologic IOP: Impact on Anterior and Posterior Segment Physiology

NCT05765201 | Completed

• 1 other identifier: Alcon IIT # 75098433
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the anterior and posterior structure and functional changes and vascular alterations when performing phacoemulsification at high IOP vs low, more physiological IOP using Centurion® Vision System with Active Sentry® handpiece. These devices are approved by the US Food and Drug Administration (FDA).

Conditions

Nuclear Cataract

Outcome Measures

Primary Outcomes (2)

• Estimated fluid usage- High IOP Group

  Measurement of fluid usage (ml).

  Intraoperative

• Estimated fluid usage- Low IOP Group

  Measurement of fluid usage (ml).

  Intraoperative

Secondary Outcomes (2)

• Macular Thickness

  post procedure at 1 week, 1 month, and 3 months

• Corneal Thickness

  post procedure at 1 day, 1 week, 1 month, and 3 months

Study Arms (2)

High IOP

Eyes in this arm will maintain an IOP of 65mmHg throughout the cataract surgery.

Other: High IOP

Low IOP

Eyes in this arm will maintain an IOP of 28mmHg throughout the cataract surgery.

Other: Low IOP

Interventions

High IOP OTHER

Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye

High IOP

Low IOP OTHER

Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye

Low IOP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

25 cataract surgery patients form ophthalmology clinic.

You may qualify if:

• No prior ocular surgery including corneal refractive surgery
• Bilateral visually significant cataract, similar in density (LOCS III grade 2+), undergoing uncomplicated cataract surgery
• Equal dilated pupil size ≥6mm, no use of pupil expansion devices
• Unremarkable systemic health but inclusive of controlled type II diabetes and hypertension with normal OCT angiography at baseline
• A1C ≤ 8% on single monotherapy or lifestyle adjustments
• To maintain high sensitivity/specificity, patients to fall under OCT normative database:
• Axial length 22-26mm
• Refractive error between -5.00D to +5.00D
• Cylinder ≤ 3.00D
• Normal K values \<47.00D
• Axial eye length cannot vary by more than 0.4 mm in an individual patient
• Normal CCT range 540µm ± 50

You may not qualify if:

• H/o corneal disease or dystrophies
• Media opacification for reasons other than cataract
• Compromised zonular integrity or stability
• Retinal and retinal vascular pathologies, age-related macular degeneration
• Glaucoma
• Patients with uncontrolled systematic diseases; including hypertension, diabetes, systemic cardiovascular diseases and hematological diseases

Sponsors & Collaborators

• Matthew Rauen: lead

Study Sites (1)

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Related Publications (6)

• Tang Y, Chen X, Zhang X, Tang Q, Liu S, Yao K. Clinical evaluation of corneal changes after phacoemulsification in diabetic and non-diabetic cataract patients, a systematic review and meta-analysis. Sci Rep. 2017 Oct 26;7(1):14128. doi: 10.1038/s41598-017-14656-7.

  PMID: 29074989 RESULT

• Li T, Guadie A, Feng L, Fan J, Jiang Z, Liu F. Influence of cataract surgery on macular vascular density in patients with myopia using optical coherence tomography angiography. Exp Ther Med. 2020 Dec;20(6):258. doi: 10.3892/etm.2020.9388. Epub 2020 Oct 27.

  PMID: 33199984 RESULT

• Zeng S, Liang C, He Y, Chen Y, Zhao Q, Dai S, Cheng F, Zhang J, Jiang X. Changes of Subfoveal Choroidal Thickness after Cataract Surgery: A Meta-Analysis. J Ophthalmol. 2018 Nov 12;2018:2501325. doi: 10.1155/2018/2501325. eCollection 2018.

  PMID: 30607294 RESULT

• Vasavada V, Raj SM, Praveen MR, Vasavada AR, Henderson BA, Asnani PK. Real-time dynamic intraocular pressure fluctuations during microcoaxial phacoemulsification using different aspiration flow rates and their impact on early postoperative outcomes: a randomized clinical trial. J Refract Surg. 2014 Aug;30(8):534-40. doi: 10.3928/1081597X-20140711-06.

  PMID: 25325894 RESULT

• Chen D, Zhu J, Li J, Ding XX, Lu F, Zhao YE. Effect of simulated dynamic intraocular pressure on retinal thickness measured by optical coherence tomography after cataract surgery. Int J Ophthalmol. 2012;5(6):687-93. doi: 10.3980/j.issn.2222-3959.2012.06.07. Epub 2012 Dec 18.

  PMID: 23275902 RESULT

• Liu X, Fang Y, Zhou Y, Wang M, Luo Y. Dynamic changes in retinal vessel density observed by optical coherence tomography angiography after phacoemulsification: active vs gravity fluidics system. Arq Bras Oftalmol. 2022 Apr 8;85(2):205-207. doi: 10.5935/0004-2749.20220093. eCollection 2022. No abstract available.

  PMID: 35416902 RESULT

Study Officials

• Matthew Rauen, MD

  Wolfe Eye Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: March 13, 2023
• Study Start: September 22, 2022
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)