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
Scientific
4055 Campbell Ave.
Menlo Park
94025
United States of America
Study information
| Study design | Prospective multicentre single arm non-randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Please contact the Clinical Affairs Department [clinical@iscienceinterventional.com] for more information or to request a patient information sheet |
| Scientific title | Dilation of Schlemms Canal during Glaucoma Surgery: A muticenter, single arm, non-randomized interventional trial |
| Study objectives | That 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) studied | 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 |
| Primary outcome measure | 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 study start date | 08/09/2005 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 157 eyes |
| Key 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 |
| Key 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 |
| Date of first enrolment | 08/09/2005 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Germany
- United States of America
Study participating centre
4055 Campbell Ave.
Menlo Park
94025
United States of America
94025
United States of America
Sponsor information
iScience Interventional Corp. (USA)
Industry
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
