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

Nuclear Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05765201
• Other study ID #: Alcon IIT # 75098433
• Status: Completed
• Start date: September 22, 2022
• Est. completion date: May 4, 2023

Study information

• Verified date: January 2024
• Source: Wolfe Eye Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 4, 2023
• Est. primary completion date: May 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Nuclear Cataract

Intervention

Other:
• High IOP
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
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

Locations

Country	Name	City	State
United States	Wolfe Eye Clinic	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Matthew Rauen

Country where clinical trial is conducted

United States, 

References & Publications (6)

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.2222-3959.2012.06.0 — View 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 — View 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: 10.5935/00 — View 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 — View 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 ran — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated fluid usage- High IOP Group	Measurement of fluid usage (ml).	Intraoperative
Primary	Estimated fluid usage- Low IOP Group	Measurement of fluid usage (ml).	Intraoperative
Secondary	Macular Thickness	Macular thickness measured in microns at week 1, month 1, and month 3. Measured by optical coherence tomography (OCT).	post procedure at 1 week, 1 month, and 3 months
Secondary	Corneal Thickness	Corneal thickness measured in microns at 1 day, week 1, month 1, and month 3. Measured by pentacam tomography.	post procedure at 1 day, 1 week, 1 month, and 3 months