Clinical trial NCT01383525: Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma
Official title: Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma . Single Site Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: SLT, LTP, DSLT
non contact
Trabeculoplasty
Laser
intraocular pressure
Lead sponsor: BelkinVision
Sponsor class: INDUSTRY
Collaborators: name: Horizon 2020 - European Commission
First posted: 2011-06-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The trial objectives are to establish the safety \& efficacy of using a DLTP laser to perform laser trabeculoplasty to reduce Intraocular Pressure (IOP) in patients with open angle glaucoma (Including Pigmentary \& Exfoliative Glaucoma), that did not achieve adequate IOP control by conventional therapy.

Detailed description: This is a single site outpatient feasibility study assessing the safety \& efficacy of the DLTP laser in the ability to reduce IOP in patients with open angle glaucoma (OAG). The investigational site will accrue patients with uncontrolled OAG. These eyes will be treated with the direct application of Direct Laser Trabeculoplasty (DLTP)/ Direct Selective Laser Trabeculoplasty automated device (DSLT).

Only one eye per patient is to be treated with the investigational device during the study.

The laser parameters used will be like these used in the Selective trabeculoplasty (SLT) device (CE/FDA approved), but all laser beams will be applied in about one-second, through the peri-limbal.

Subjects will be evaluated preoperatively and postoperatively at 1 hour, 2 hours (and hourly to 4 hours in the event of an IOP elevation in the immediate postop course), 1 day, 1 week, and 1, 3, 6 months.

Patients will be followed out to 6 months.

Eligibility 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 6-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 Direct Selective Trabeculoplasty (DSLT)
* Having concurrent treatment with systemic steroids.
* Patient is under 18 years old

Primary outcomes:
measure: Reduction of Intra-Ocular pressure
timeFrame: 1,3 month
Secondary outcomes:
measure: Reduction of Intra-Ocular pressure
timeFrame: 6 months
Other outcomes:
measure: Number of medications
timeFrame: 6 months
measure: Physician perception of the usability of the system.
timeFrame: 1 month
Locations:
city: Ramat-Gan
country: Israel
facility: The Sam Rothberg Glaucoma Center Goldschleger Eye Institute Sheba meical Center
Study officials:
affiliation: Sheba Medical Center
name: Alon Skaat, MD
role: PRINCIPAL_INVESTIGATOR
References: