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

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
Email drdancalladine@doctors.org.uk

Study information

Study designProspective consecutive randomised case-controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe use of I-ZIP® Adherent Ocular Bandage to help cataract surgery incisions seal more effectively: a prospective consecutive randomised case-controlled study
Study acronymI-ZIP®
Study objectivesTo 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) studiedEndophthalmitis/cataract surgery
InterventionThe 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 typeOther
Primary outcome measureMeasured 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 measuresNo secondary outcome measures
Overall study start date18/06/2009
Completion date30/12/2009

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants50 patients - 25 patients treated with I-ZIP® and 25 patients in the control arm
Key inclusion criteria1. 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 criteria1. Anterior segment ocular disease
2. Corneal endothelial dystropy
3. Complicated cataract surgery
4. Corneal suture
5. Stromal hydration required
Date of first enrolment18/06/2009
Date of final enrolment30/12/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Ophthalmology
Windsor
SL4 3DP
United Kingdom

Sponsor information

Royal Berkshire NHS Foundation Trust (UK)
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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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