The use of I-ZIP® Adherent Ocular Bandage to help cataract surgery incisions seal more effectively
| ISRCTN | ISRCTN64880258 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64880258 |
| Secondary identifying numbers | Protocol 1, version 2 |
- Submission date
- 09/07/2009
- Registration date
- 04/09/2009
- Last edited
- 31/01/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Daniel Calladine
Scientific
Scientific
Department of Ophthalmology
Prince Charles Eye Unit
King Edward VII Hospital
St Leonard's Road
Windsor
SL4 3DP
United Kingdom
| Phone | +44 (0)7837 372 415 |
|---|---|
| drdancalladine@doctors.org.uk |
Study information
| Study design | Prospective consecutive randomised case-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The use of I-ZIP® Adherent Ocular Bandage to help cataract surgery incisions seal more effectively: a prospective consecutive randomised case-controlled study |
| Study acronym | I-ZIP® |
| Study objectives | To determine whether I-ZIP® improves the sealing and architectural profile of clear cornear incisions and reduce the risks of leaking and endophthalmitis. |
| Ethics approval(s) | Berkshire Ethics Committee approved on the 9th June 2009 (ref: 09/H0505/35) |
| Health condition(s) or problem(s) studied | Endophthalmitis/cataract surgery |
| Intervention | The methodology is identical for both arms, except for the application of the I-ZIP® bandage in the treatment arm, or not in the control arm. Both arms will receive clear corneal incision 2.2.mm wide micro coaxial phacoemulsification cataract surgery. The intraocular lens will be injected using C-cartridge and wound-assisted techniques. Patients will then be receive either the application of I-ZIP®, or not. Within 1 hour of completing surgery: optical coherence tomography (OCT) examination Within 2 hours of completing surgery: slit lamp examination using 2% fluorescein and measurement of intraocular pressure (IOP) Day 1 post-operative examination: OCT, slit lamp and IOP, slit lamp photograph Day 7 post-operative examination: OCT, slit lamp and IOP |
| Intervention type | Other |
| Primary outcome measure | Measured less than 1 hour, less than 2 hours, 1 day and 7 days post-operatively: 1. Optical Coherence Tomography (OCT) wound architecture 2. Intra-ocular pressure |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 18/06/2009 |
| Completion date | 30/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 50 patients - 25 patients treated with I-ZIP® and 25 patients in the control arm |
| Key inclusion criteria | 1. Routine cataract surgery 2. 2.2 mm wide clear corneal incision 3. No wound enlargement 4. No stromal hydration of wound 5. Typical "older patient" of either sex, no specific age limits |
| Key exclusion criteria | 1. Anterior segment ocular disease 2. Corneal endothelial dystropy 3. Complicated cataract surgery 4. Corneal suture 5. Stromal hydration required |
| Date of first enrolment | 18/06/2009 |
| Date of final enrolment | 30/12/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Ophthalmology
Windsor
SL4 3DP
United Kingdom
SL4 3DP
United Kingdom
Sponsor information
Royal Berkshire NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Office
Level 3, New Main Entrance
Craven Road
Reading
RG1 5AN
England
United Kingdom
| Website | http://www.royalberkshire.nhs.uk/Default.aspx?theme=Patient |
|---|---|
"ROR" |
https://ror.org/034nvrd87 |
Funders
Funder type
Industry
I-Therapeutix, Inc. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2010 | Yes | No |
