Condition category
Eye Diseases
Date applied
09/07/2009
Date assigned
04/09/2009
Last edited
31/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.royalberkshire.nhs.uk/Default.aspx?theme=Patient

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

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21029890

Publication citations

  1. 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.

Additional files

Editorial Notes