Direct Application of Selective Laser Trabeculoplasty Using the "DIO-DENT 10" in Open Angle Glaucoma (SLT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
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
  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:


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:
  • "DIO-DENT 10" DENTAL DIODE LASER SYSTEM
  • 510(k)NumberK 03 181 4
  • SLT
  • non contact
Device: Direct application of SLT in Open Angle Glaucoma
Direct application of Selective Laser Trabeculoplasty in Open Angle Glaucoma
Other Names:
  • Direct
  • Selective Laser Trabeculoplasty
  • Open Angle Glaucoma

  Hide Detailed Description

Detailed Description:

Number of patients: An enrollment of approximately 25 patients is planned to be treated with the Direct application of Selective Laser Trabeculoplasty.

This is a single site outpatient study assessing the safety & efficacy of the TSLTP laser (TSLTP))( "DIO-DENT 10" DENTAL DIODE LASER SYSTEM ) in the ability to reduce IOP in patients with open angle glaucoma. 20 patients are to be enrolled in the study. The investigational site will accrue patients with uncontrolled open-angle glaucoma. These eyes will be treated with the direct application of Selective Laser Trabeculoplasty (TSLTP).

Only one eye per patient is to be treated during the study interval up to 3 months. Thereafter the treatment of the fellow eye may be done per the medical judgment of the investigator.

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

The interval for evaluation of equivalence of the two trabeculoplasty procedures is 6 months. Patients will be followed out to 3 months.

Investigational Device The TSLTP laser, "DIO-DENT 10" DENTAL DIODE LASER SYSTEM is a flash-lamp-excited solid-state laser emitting in the near infrared at 790 nm. It is used to perform either direct application of Selective Laser Trabeculoplasty to the conjunctiva just above the trabecular Meshwork (TM). The laser and slit-lamp delivery system combine to form a system that focuses the treatment beam onto the conjunctiva. An aiming beam, coincident with the treatment beam, is used to direct placement of the treatment beam onto the conjunctiva. Pressing a footswitch delivers the treatment beam in the form of a short pulse of energy approximately 8 us in duration.

Study Procedures and Evaluations

Operative Procedure Only one eye per patient is to be treated during the study up to the 6 month interval. The treating physician will use his/her medical judgment in determining which eye should be treated based on current IOP and general ocular and visual status of the patient's treated eye and fellow eye.

Topical anesthesia is administered to the eye to be treated prior to treatment. the DSALT will be used, than the aiming beam is placed just above the TM .

Patients will be treated with a TSLTP laser (790 nm) over a 360 degree arc, with 100 spots. The energy level used will be determined on a patient by patient basis based on the threshold needed to achieve an effect on the tissue. Placement of the spots, inferior, superior, temporal or nasal will be documented. Immediately following the laser treatment, Diclofenac drops are administered and continued in the treated eye four times daily for four to seven days.

Preoperative and Postoperative Procedures and Evaluations A schedule of preoperative and postoperative procedures and evaluations is provided in Table B.

Preoperative Procedures and Evaluations

The variability of IOP in patients is monitored for two consecutive weeks before treatment begins. The examination at the first screening visit is conducted two to six weeks before treatment and includes a full ophthalmic examination of both eyes, consisting of the following:

  • Two readings of IOP by applanation.
  • Determination of best corrected visual acuity.
  • Slit-lamp examination of the anterior segment.

    • Conjunctival injection (0-4+)
    • Cornea appearance
    • Iris and lens appearance
    • Anterior Chamber Cell and Flare (0-4+)
  • Gonioscopy with grading of the degree of pigmentation in each quadrant.
  • Evaluation of angle opening.
  • Evaluation of presence of posterior anterior synechiae (PAS).
  • Lens examination.
  • Determination of ratio of optic disc cupping.
  • Fundus examination.
  • Visual field examination (could be performed within the 6 weeks before treatment, including the day of treatment).
  • Recording of current glaucoma medications (type and dosage).
  • Recording of date and time of last administration of each listed glaucoma medication.

Patient demographic information (sex, race, and date of birth) and a medical history that includes previous ocular surgery are also recorded.

At least four days should elapse between the initial and the second screening examinations. The following are assessed and recorded for both eyes:

  • Date and time of the evaluation.
  • Results of two readings of IOP by applanation.
  • Current glaucoma medications (type and dosage).
  • Date and time of the latest administration of each listed glaucoma medication.

Finally, the following are assessed and recorded for both eyes immediately before treatment begins.

  • Results of two readings of IOP by applanation.
  • Best corrected visual acuity.
  • Glaucoma medications (number, type, and dosage).
  • Date and time of latest administration of each listed glaucoma medication.

Postoperative Observations and Follow-Up Immediately following treatment, two readings of the IOP in the treated eye are assessed and recorded for at least 2 hours postoperatively. The IOP continues to be monitored on an hourly basis if there is an IOP rise *5 mmHg from the immediate preoperative IOP. If necessary, the elevated IOP is treated with appropriate increase in anti-glaucoma medications and the administration of the additional medications is recorded.

The presence and level of cells in the anterior chamber are recorded at each hourly examination. Any immediate postoperative complications or complaints are recorded.

The IOP management medications will be maintained throughout the treatment and the post-treatment follow-up intervals. Any anti-glaucoma medication regimen adjustments needed are instituted and recorded.

At the examination on the day following treatment, as well as all subsequent scheduled and unscheduled examinations, the physician or technician measuring the IOP is blinded with regard to which eye had received the TSLTP. At this visit, the following are assessed and recorded:

  • IOP by applanation in both eyes.
  • Glaucoma medications (type and dosage).
  • Date and time of last administration of each listed glaucoma medication.
  • Slit-lamp examination of the anterior segment in the treated eye.

    • Conjunctival injection (0-4+)
    • Anterior chamber cell and flare (0-4+)
    • Iris and lens appearance
    • Cornea appearance

At Weeks 1 and 4 the following are assessed and recorded:

  • IOP by applanation in both eyes.
  • Best corrected visual acuity in both eyes.
  • Glaucoma medications (type and dosage).
  • Date and time of last administration of each listed glaucoma medication.
  • Slit-lamp examination of the anterior segment in the treated eye.

    • Conjunctival injection (0-4+)
    • Anterior chamber cell and flare (0-4+)
    • Iris and lens appearance
    • Cornea appearance

At Months 3 the following are assessed and recorded for both eyes:

  • Two readings of IOP by applanation.
  • Best corrected visual acuity.
  • Glaucoma medications (type and dosage).
  • Date and time of last administration of each listed glaucoma medication.
  • Slit-lamp examination of the anterior segment:

    • Conjunctival injection (0-4+)
    • Anterior chamber cells and flare (0-4+)
    • Iris and lens appearance
    • Cornea appearance
  • Gonioscopy with grading of the degree of pigmentation in each quadrant.
  • Evaluation of angle opening.
  • Evaluation of presence of PAS.
  • Lens examination.
  • Determination of ratio of optic disc cupping.
  • Fundus examination.
  • Visual field examination.
  • Recording of current glaucoma medications (type and dosage).
  • Recording of date and time of last administration of each listed glaucoma medication.

Additional or more frequent follow-up evaluations could be performed at the investigator's request.

Safety and Efficacy Variables

Criteria for evaluation: Efficacy:

Primary Efficacy Endpoint:

The primary efficacy endpoint is the percentage reduction in IOP at 6 months postoperative from preoperative medicated IOP. The mean percentage reduction in IOP will be assessed .

Secondary Efficacy Endpoints The following efficacy endpoints will be compared between the two treatment groups.

  • Postoperative IOP at 3, 6 and 12 months
  • Absolute reduction and percentage reduction in IOP at 3, 6 and 12 months from preoperative medicated IOP
  • The relationship between preoperative medicated IOP and the change in IOP at 3, 6, and 12 months following treatment.

Safety: Safety will be determined by frequency tabulations of adverse events and complications such as the following:

  • Acute elevation of IOP *10 mmHg above the immediate preoperative measurement in either the treated or non-treated eye.
  • Mild or moderate anterior chamber inflammation in the treated eye, including iritis, cells and flare.
  • Any of the following in the treated eye:
  • transient blurred vision;
  • discomfort; pain
  • deterioration of visual field;
  • mild hemorrhage
  • loss of more than 2 lines of BCVA, associated with the procedure

Safety will also be determined by evaluating the change from baseline following TSLTP treatment in other ocular characteristics such as

  • cells and flare,
  • visual acuity, and
  • disc cup to disc ratio

All patients enrolled and treated in the study will be evaluated for safety.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014