Contact information
Type
Scientific
Primary contact
Dr Daniel Calladine
ORCID ID
Contact details
Department of Ophthalmology
Prince Charles Eye Unit
King Edward VII Hospital
St Leonard's Road
Windsor
SL4 3DP
United Kingdom
+44 (0)7837 372 415
drdancalladine@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol 1, version 2
Study information
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
Acronym
I-ZIP®
Study hypothesis
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
Berkshire Ethics Committee approved on the 9th June 2009 (ref: 09/H0505/35)
Study design
Prospective consecutive randomised case-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
18/06/2009
Overall trial end date
30/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
50 patients - 25 patients treated with I-ZIP® and 25 patients in the control arm
Participant exclusion criteria
1. Anterior segment ocular disease
2. Corneal endothelial dystropy
3. Complicated cataract surgery
4. Corneal suture
5. Stromal hydration required
Recruitment start date
18/06/2009
Recruitment end date
30/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Ophthalmology
Windsor
SL4 3DP
United Kingdom
Sponsor information
Organisation
Royal Berkshire NHS Foundation Trust (UK)
Sponsor details
Research and Development Office
Level 3
New Main Entrance
Craven Road
Reading
RG1 5AN
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
I-Therapeutix, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21029890
Publication citations
-
Results
Calladine D, Ward M, Packard R, Adherent ocular bandage for clear corneal incisions used in cataract surgery., J Cataract Refract Surg, 2010, 36, 11, 1839-1848, doi: 10.1016/j.jcrs.2010.06.058.