Condition category
Eye Diseases
Date applied
30/08/2010
Date assigned
07/10/2010
Last edited
31/01/2012
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

Ms Stephanie Baba

ORCID ID

Contact details

4055 Campbell Ave.
Menlo Park
94025
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OMS-2005

Study information

Scientific title

Dilation of Schlemm’s Canal during Glaucoma Surgery: A muticenter, single arm, non-randomized interventional trial

Acronym

Study hypothesis

That the use of the iScience microcatheter in the treatment of open angle glaucoma is safe and effective.

Ethics approval

The Freiburg Ethics Commission International (FECI) approved on the 8th of September 2005 (ref: 05/1462)

Study design

Prospective multicentre single arm non-randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Please contact the Clinical Affairs Department [clinical@iscienceinterventional.com] for more information or to request a patient information sheet

Condition

Open-angle glaucoma

Intervention

Canaloplasty, a procedure involving circumferential viscodilation and tensioning of the inner wall of Schlemm’s canal for the treatment of open-angle glaucoma This is a single-arm study.
The total duration of follow-up is 3 years.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Intraocular pressure in mm Hg, measured at baseline, 1 day, 1 week, and then at 1, 3, 6, 12, 18, 24, 30, and 36 months using tonometry.
2. Number of glaucomatous medications, obtained during patient visits and recorded via case report forms.

Secondary outcome measures

1. Nature and frequency of surgical and post-surgical complications
2. Number of secondary interventions
Obtained during patient visits and recorded via case report forms.

Overall trial start date

08/09/2005

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. At minimum 18 years of age
2. Scheduled for glaucoma surgery or combined cataract and glaucoma surgery
3. Diagnosis or primary open-angle glaucoma (POAG), pigmentary glaucoma, exfoliative glaucoma, or POAG mixed with another included mechanism
4. Baseline intraocular pressure of 16 mm Hg or higher and a historical IOP of 21 mm Hg or higher
5. Either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

157 eyes

Participant exclusion criteria

1. Neovascular disease
2. Uveitis
3. Peripheral anterior synechiae
4. Angle recession
5. Developmental or secondary glaucoma with the exception of pigmentary and exfoliative glaucoma
6. Previous ocular surgeries that would interfere with complete circumferential catheterization of Schlemm’s canal
7. Patients with more than two laser trabeculoplasty procedures

Recruitment start date

08/09/2005

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Germany, United States of America

Trial participating centre

4055 Campbell Ave.
Menlo Park
94025
United States of America

Sponsor information

Organisation

iScience Interventional Corp. (USA)

Sponsor details

4055 Campbell Ave
Menlo Park
94025
United States of America

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

iScience Interventional Corp (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. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21732110

Publication citations

  1. Results

    Bull H, von Wolff K, Körber N, Tetz M, Three-year canaloplasty outcomes for the treatment of open-angle glaucoma: European study results., Graefes Arch. Clin. Exp. Ophthalmol., 2011, 249, 10, 1537-1545, doi: 10.1007/s00417-011-1728-3.

Additional files

Editorial Notes