Titanium-Sapphire Laser Trabeculoplasty in Glaucoma: A Randomized Study Comparing Titanium-Sapphire With Argon Laser Trabeculoplasty in Open-Angle Glaucoma Patients
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|ClinicalTrials.gov Identifier: NCT00470964|
Recruitment Status : Completed
First Posted : May 8, 2007
Last Update Posted : May 8, 2007
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma, Open-Angle||Procedure: Titanium Sapphire laser trabeculoplasty||Not Applicable|
Goldschleger Eye Institute has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
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)|
|Intervention Model:||Parallel Assignment|
U.S. FDA Resources
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 ClinicalTrials.gov identifier (NCT number): NCT00470964
|Goldschleger Eye Institute|
|Ramat Gan, Israel, 52621|
|Principal Investigator:||Shlomo Melamed, MD||Goldschleger Eye Institute|