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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00470964
Recruitment Status : Completed
First Posted : May 8, 2007
Last Update Posted : May 8, 2007
Information provided by:
Goldschleger Eye Institute

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

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Procedure: Titanium Sapphire laser trabeculoplasty Not Applicable

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

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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Primary Outcome Measures :
  1. IOP

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 91 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Uncontrolled open angle glaucoma patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00470964

Goldschleger Eye Institute
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Goldschleger Eye Institute
Principal Investigator: Shlomo Melamed, MD Goldschleger Eye Institute Identifier: NCT00470964     History of Changes
Other Study ID Numbers: 105-0011-001
First Posted: May 8, 2007    Key Record Dates
Last Update Posted: May 8, 2007
Last Verified: May 2007

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

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