CataractENHANSENCT04637685
The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery; the ENHANSE Study
A study testing Centurion Phacoemulsification System in people with Cataract, run by South Tyneside and Sunderland NHS Foundation Trust.
Trial summary
The effect of infusion pressure on the outcomes of phacoemulsification surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Centurion Phacoemulsification System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with cataract undergoing routine phacoemulsification with either diabetic retinopathy or glaucoma of any degree
Who cannot join
- Dense cataract precluding adequate retinal imaging
- posterior polar cataract
- subluxated cataract,
- other vision affecting pathology,
- severe glaucoma
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Enhanse Study The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery
The effect of infusion pressure on the outcomes of phacoemulsification surgery.
Read the detailed 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.
- Conditions
- Cataract
- Being tested
- Centurion Phacoemulsification System
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centurion Phacoemulsification SystemDevice
Infusion Pressure
| Study group | Role | What they receive |
|---|---|---|
| Standard pressure | Active comparator | Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 70mmHg Receives: Device: Centurion Phacoemulsification System |
| Low or physiological pressure | Active comparator | Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 30mmHg Receives: Device: Centurion Phacoemulsification System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From the start to the end of the 10 month planned recruitment period
Secondary outcomes (2)
Retinal thickness on SD OCT
The above will be measured preoperatively and compared with day 40
Measured: Between baseline and day 40
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
Measured: Between baseline and day 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Tyneside and Sunderland NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Steel, Principal investigator, South Tyneside and Sunderland NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637685
- Sponsor's protocol ID
- 288743
- Acronym
- ENHANSE
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Enhanse Study The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery
- ClinicalTrials.gov ID
- NCT04637685
- Acronym / sponsor ID
- ENHANSE / 288743
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- South Tyneside and Sunderland NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of infusion pressure on the outcomes of phacoemulsification surgery.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard pressure | Active comparator | Device: Centurion Phacoemulsification SystemInfusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 70mmHg |
| Low or physiological pressure | Active comparator | Device: Centurion Phacoemulsification SystemInfusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 30mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with cataract undergoing routine phacoemulsification with either diabetic retinopathy or glaucoma of any degree
Key exclusion criteria (5 listed)
- Dense cataract precluding adequate retinal imaging
- posterior polar cataract
- subluxated cataract,
- other vision affecting pathology,
- severe glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Centurion Phacoemulsification SystemInfusion Pressure | Device | Low or physiological pressure, Standard pressure |
Primary outcome
Recruitment rate
Time frame: From the start to the end of the 10 month planned recruitment period
The study has been designed as a feasibility study to assess recruitment rate. We will measure rate of recruitment to study (persons per month)
2 secondary outcomes
Retinal thickness on SD OCT
Time frame: Between baseline and day 40
Foveal avascular zone size on optical coherence tomography angiography between baseline and day 40
Time frame: Between baseline and day 40
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Steel principal investigator
South Tyneside and Sunderland NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing Centurion Phacoemulsification System in people with Cataract, run by South Tyneside and Sunderland NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steve Dodds (+441915699039, steven.dodds@chsft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: From the start to the end of the 10 month planned recruitment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.