Clinical trial NCT05765201: Phacoemulsification at High IOP and Physiologic IOP: Impact on Anterior and Posterior Segment Physiology
Official title: Phacoemulsification at High IOP and Physiologic IOP: Impact on Anterior and Posterior Segment Physiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nuclear Cataract
Lead sponsor: Wolfe Eye Clinic
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 cataract surgery patients form ophthalmology clinic.

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).

Detailed description: To investigate the anterior and posterior physiological changes when performing phacoemulsification at high IOP vs low, more physiologic IOP using Centurion® Vision System with Active Sentry® handpiece

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

Operating at lower, more physiological IOP using Active Sentry® handpiece during cataract surgery will use less BSS fluid usage. (Lower IOP settings are also expected to result in less subclinical changes).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Estimated fluid usage- High IOP Group
timeFrame: Intraoperative
measure: Estimated fluid usage- Low IOP Group
timeFrame: Intraoperative
Secondary outcomes:
measure: Macular Thickness
timeFrame: post procedure at 1 week, 1 month, and 3 months
measure: Corneal Thickness
timeFrame: post procedure at 1 day, 1 week, 1 month, and 3 months
Other outcomes:
Locations:
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
Study officials:
affiliation: Wolfe Eye Clinic
name: Matthew Rauen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.