Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OMS-2005
Study information
Scientific title
Dilation of Schlemms 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 Schlemms 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 Schlemms 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
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
-
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.