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 |
| Protocol serial number | Protocol 1, version 2 |
| Sponsor | Royal Berkshire NHS Foundation Trust (UK) |
| Funder | I-Therapeutix, Inc. (USA) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective consecutive randomised case-controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Measured less than 1 hour, less than 2 hours, 1 day and 7 days post-operatively: |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 50 |
| 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
- United Kingdom
- England
Study participating centre
Department of Ophthalmology
Windsor
SL4 3DP
United Kingdom
SL4 3DP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
