The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery; the ENHANSE Study

Cataract Clinical Trial

— ENHANSE  

Official title:

The Enhanse Study The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04637685
• Other study ID #: 288743
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: October 2020
• Source: South Tyneside and Sunderland NHS Foundation Trust
• Contact: Steve Dodds
• Phone: +441915699039
• Email: steven.dodds[@]chsft.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The effect of infusion pressure on the outcomes of phacoemulsification surgery.

Description:

The Centurion phacoemulsification system with active sentry allows efficient cataract surgery with safe use of high vacuums, whilst allowing low and physiological infusion pressures, significantly lower than other surgical systems. There are reasons to expect that this will lead to patient benefit but it is uncertain if low infusion pressure during phacoemulsification will lead to improved outcomes. This is of particular interest in patients with vascular retinopathies such as diabetic retinopathy where the retinal vasculature is compromised, as well as glaucoma and other optic neuropathies where there is established nerve fibre layer loss.

The investigator will carry out a feasibility study with a two surgeon RCT of 70 patients with diabetic retinopathy and/or glaucoma undergoing phacoemulsification with randomisation of two different infusion pressures (low (30mmHg) versus the higher pressure (~70mmHg) as currently used) using the active sentry system with assessment of a range of exploratory endpoints.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: September 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with cataract undergoing routine phacoemulsification with either diabetic retinopathy or glaucoma of any degree

Exclusion Criteria:

• Dense cataract precluding adequate retinal imaging

• posterior polar cataract

• subluxated cataract,

• other vision affecting pathology,

• severe glaucoma

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Centurion Phacoemulsification System
Infusion Pressure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
South Tyneside and Sunderland NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	The study has been designed as a feasibility study to assess recruitment rate. We will measure rate of recruitment to study (persons per month)	From the start to the end of the 10 month planned recruitment period
Secondary	Retinal thickness on SD OCT	The above will be measured preoperatively and compared with day 40	Between baseline and day 40
Secondary	Foveal avascular zone size on optical coherence tomography angiography between baseline and day 40	The above will be measured preoperatively and compared with day 40	Between baseline and day 40