Direct Application of Selective Laser Trabeculoplasty Using the "DIO-DENT 10" in Open Angle Glaucoma (SLT)
This study is currently recruiting participants.
Verified June 2012 by Sheba Medical Center
Sponsor:
Sheba Medical Center
Information provided by (Responsible Party):
Dr. Modi Goldenfeld, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01383525
First received: June 22, 2011
Last updated: June 10, 2012
Last verified: June 2012
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Purpose
The trial objectives are to establish the safety & efficacy of using the "DIO-DENT 10" DENTAL DIODE LASER SYSTEM , a TSLTP laser (790 nanometers) to perform laser trabeculoplasty (TSLTP) to reduce IOP in patients with open angle glaucoma. (Including Pigmentary & Exfoliative Glaucoma) that have poorly controlled IOP.in a Non-Contact mode
| Condition | Intervention |
|---|---|
|
Glaucoma |
Device: Direct application of Selective Laser Trabeculoplasty Device: Direct application of SLT in Open Angle Glaucoma |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Direct Application of Selective Laser Trabeculoplasty,Using the "DIO-DENT 10" DENTAL DIODE LASER SYSTEM in Open Angle Glaucoma . Single Site Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by Sheba Medical Center:
Primary Outcome Measures:
- Reduction of Intra-Ocular pressure [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Reduction of intra-ocular pressure following the non contact selective laser trabeculoplasty treatment
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SLT
Uncontrolled open angle glaucoma patients who are eligible to be treated with selective laser trabeculoplasty
|
Device: Direct application of Selective Laser Trabeculoplasty
Direct application of SLT using "DIO-DENT 10" DENTAL DIODE LASER SYSTEM to the conjunctiva over the TM
Other Names:
Device: Direct application of SLT in Open Angle Glaucoma
Direct application of Selective Laser Trabeculoplasty in Open Angle Glaucoma
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient is aged 18 years or older, with 2 sighted eyes.
- Eye to be treated have average IOP *22 mmHg, measured at 2 pretreatment visits.
- Eye to be treated either exhibits:
- poorly controlled open angle glaucoma including Pigmentary & Exfoliative Glaucoma
- Patient would be considered eligible for conventional laser trabeculoplasty.
- Patient is willing to participate in the 3-month study and to adhere to the follow-up schedule.
- Patient is willing to review and sign a consent form.
Exclusion Criteria:
- evidence of glaucoma other than open-angle glaucoma;
- severe para-central or generalized field defect;
- Any ocular condition that precluded adequate visualization and treatment of the trabecular meshwork.
- Prior glaucoma surgery other than laser trabeculoplasty or peripheral iridotomy.
- Patient has mental impairment such that he/she could not understand the protocol or is not in a position to provide written informed consent.
- Patient is pregnant.
- Patient might require other ocular surgery within the 6-month follow-up period.
- Patient has a medical history that suggested the potential for complications from TSLTP.
- Having concurrent treatment with systemic steroids.
- Patient is under 18 years old
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383525
Locations
| Israel | |
| The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center | Recruiting |
| Tel Hashomer Ramat-Gan, Israel, 52621 | |
| Contact: Mordechai Goldenfeld, MD 972353023046 modigold@goldenfeld.co.il | |
| Contact: Michael Belkin, MD 9723-5302956 belkin@netvision.net.il | |
Sponsors and Collaborators
Sheba Medical Center
Investigators
| Principal Investigator: | Mordechai Goldenfeld, MD | Sheba Medical Center |
| Study Chair: | Michael Belkin, MD | Tel Aviv University |
More Information
No publications provided
| Responsible Party: | Dr. Modi Goldenfeld, M.D., Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT01383525 History of Changes |
| Other Study ID Numbers: | SHEBA-11-8414-MG-CTIL |
| Study First Received: | June 22, 2011 |
| Last Updated: | June 10, 2012 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Sheba Medical Center:
|
SLT non contact Trabeculoplasty Laser intraocular pressure |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013