Clinical Trials Directory

Trials / Completed

CompletedNCT00470964

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
Sponsor
Goldschleger Eye Institute · Academic / Other
Sex
All
Age
40 Years – 91 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETitanium Sapphire laser trabeculoplasty

Timeline

First posted
2007-05-08
Last updated
2007-05-08

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT00470964. Inclusion in this directory is not an endorsement.