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

South Tyneside and Sunderland NHS Foundation Trust

Status: Unknown

Conditions: Cataract

Treatments: Device: Centurion Phacoemulsification System

Study type: Interventional

Funder types: Other

Identifiers

NCT04637685

288743

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Standard pressure

Active Comparator group

Description:

Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 70mmHg

Treatment:

Device: Centurion Phacoemulsification System

Low or physiological pressure

Active Comparator group

Description:

Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 30mmHg

Treatment:

Device: Centurion Phacoemulsification System