Dilation of Schlemm's Canal during Glaucoma Surgery

ISRCTN ISRCTN12425531
DOI https://doi.org/10.1186/ISRCTN12425531
Secondary identifying numbers OMS-2005
Submission date
30/08/2010
Registration date
07/10/2010
Last edited
31/01/2012
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

Ms Stephanie Baba
Scientific

4055 Campbell Ave.
Menlo Park
94025
United States of America

Study information

Study designProspective multicentre single arm non-randomised interventional trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Please contact the Clinical Affairs Department [clinical@iscienceinterventional.com] for more information or to request a patient information sheet
Scientific titleDilation of Schlemm’s Canal during Glaucoma Surgery: A muticenter, single arm, non-randomized interventional trial
Study objectivesThat the use of the iScience microcatheter in the treatment of open angle glaucoma is safe and effective.
Ethics approval(s)The Freiburg Ethics Commission International (FECI) approved on the 8th of September 2005 (ref: 05/1462)
Health condition(s) or problem(s) studiedOpen-angle glaucoma
InterventionCanaloplasty, 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date08/09/2005
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants157 eyes
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment08/09/2005
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Germany
  • United States of America

Study participating centre

4055 Campbell Ave.
Menlo Park
94025
United States of America

Sponsor information

iScience Interventional Corp. (USA)
Industry

4055 Campbell Ave
Menlo Park
94025
United States of America

Funders

Funder type

Industry

iScience Interventional Corp (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 01/10/2011 Yes No