Cataract
Conditions
Brief summary
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.
Interventions
DEVICECenturion Phacoemulsification System
Infusion Pressure
Sponsors
South Tyneside and Sunderland NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
All outcome assessors will be masked to treatment group allocation. The surgeon will not be masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retinal thickness on SD OCT | Between baseline and day 40 | The above will be measured preoperatively and compared with day 40 |
| Foveal avascular zone size on optical coherence tomography angiography between baseline and day 40 | Between baseline and day 40 | The above will be measured preoperatively and compared with day 40 |
Contacts
Primary ContactSteve Dodds
Backup ContactDavid Steel
Outcome results
None listed