Titanium-Sapphire Laser Trabeculoplasty in Glaucoma: A Randomized Study Comparing Titanium-Sapphire With Argon Laser Trabeculoplasty in Open-Angle Glaucoma Patients

This study has been completed.
Sponsor:
Information provided by:
Goldschleger Eye Institute
ClinicalTrials.gov Identifier:
NCT00470964
First received: May 6, 2007
Last updated: May 7, 2007
Last verified: May 2007
  Purpose

Titanium Sapphire laser trabeculoplasty is effective in lowering intraocular pressure in glaucoma patients, and is comparable to argon laser trabeculoplasty


Condition Intervention
Glaucoma, Open-Angle
Procedure: Titanium Sapphire laser trabeculoplasty

Goldschleger Eye Institute has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind

Resource links provided by NLM:


Further study details as provided by Goldschleger Eye Institute:

Primary Outcome Measures:
  • IOP

Detailed Description:

Objective: To compare the medium-term outcome of Titanium-Sapphire laser trabeculoplasty (TiSLT) vs. Argon Laser Trabeculoplasty (ALT) in uncontrolled Open-angle Glaucoma (OAG) patients.

Methods: Prospective, masked, randomized comparative clinical study. Thirty-seven OAG patients with uncontrolled IOP and no previous filtration surgery (22 females and 15 males, mean age of 68 years) participated. Eighteen were treated with TiSLT and 19 with ALT. All patients underwent a comprehensive eye examination including visual acuity, IOP, goniocscopy and slit-lamp biomicroscopy and visual field examinations. Patients were examined pre-operatively and then at 1 hour, 1 day, 1 week, 1, 3 and 6 months, 1 year and 18 months post-operatively.

Main outcome measures: Final IOP, delta IOP and number of anti-glaucoma medications.

Results: The 18 patients in the TiSLT arm had an average of 8.3(±2.7) mm Hg or 32% reduction from pre-operative IOP (P<0.001). The 19 patients in the ALT arm had a mean IOP decrease of 6.5 (±4.3) mm Hg (P<0.001) or a 25% IOP reduction. Patients in both groups achieved a similar decrease in IOP (P>0.05). TiSLT patients had statistically significant fewer IOP spikes compared to the ALT group. (P=0.002). Two patients (1 in each arm) underwent trabeculectomy and were considered failures. Mean follow-up time was 15 months.

Conclusions: TiSLT provides similar efficacy to ALT in IOP reduction in OAG patients, and may offer better safety with fewer IOP spikes see post-operatively.

Application to clinical practice: If confirmed in additional studies, TiSLT may be used as an alternative to ALT in OAG patients.

  Eligibility

Ages Eligible for Study:   40 Years to 91 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uncontrolled open angle glaucoma patients
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00470964

Locations
Israel
Goldschleger Eye Institute
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Goldschleger Eye Institute
Investigators
Principal Investigator: Shlomo Melamed, MD Goldschleger Eye Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00470964     History of Changes
Other Study ID Numbers: 105-0011-001
Study First Received: May 6, 2007
Last Updated: May 7, 2007
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
United States: Food and Drug Administration

Keywords provided by Goldschleger Eye Institute:
laser trabeculoplasty, glaucoma, argon, titanium-sapphire
IOP lowering effect
Adverse effects
IOP spikes

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014