Titanium-Sapphire Laser Trabeculoplasty in Glaucoma: A Randomized Study Comparing Titanium-Sapphire With Argon Laser Trabeculoplasty in Open-Angle Glaucoma Patients
NCT ID: NCT00470964
Last Updated: 2007-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Interventions
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Titanium Sapphire laser trabeculoplasty
Eligibility Criteria
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Inclusion Criteria
40 Years
91 Years
ALL
No
Sponsors
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Goldschleger Eye Institute
OTHER
Principal Investigators
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Shlomo Melamed, MD
Role: PRINCIPAL_INVESTIGATOR
Goldschleger Eye Institute
Locations
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Goldschleger Eye Institute
Ramat Gan, , Israel
Countries
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Other Identifiers
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105-0011-001
Identifier Type: -
Identifier Source: org_study_id