MedDataX Logo

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

NCT ID: NCT04637685

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
All outcome assessors will be masked to treatment group allocation. The surgeon will not be masked.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard pressure

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

Group Type ACTIVE_COMPARATOR

Centurion Phacoemulsification System

Intervention Type DEVICE

Infusion Pressure

Low or physiological pressure

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

Group Type ACTIVE_COMPARATOR

Centurion Phacoemulsification System

Intervention Type DEVICE

Infusion Pressure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Centurion Phacoemulsification System

Infusion Pressure

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

South Tyneside and Sunderland NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Steel

Role: PRINCIPAL_INVESTIGATOR

South Tyneside and Sunderland NHS Trust

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Steve Dodds

Role: CONTACT

Phone: +441915699039

Email: [email protected]

David Steel

Role: CONTACT

Phone: +441915656256

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

288743

Identifier Type: -

Identifier Source: org_study_id