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NCT00470964 Clinical Trial

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

Glaucoma, Open-Angle Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00470964
Other study ID # 105-0011-001
Secondary ID
Status Completed
Phase N/A
First received May 6, 2007
Last updated May 7, 2007

Study information
Verified date May 2007
Source Goldschleger Eye Institute
Contact n/a
Is FDA regulated No
Health authority Israel: The Israel National Institute for Health Policy Research and Health Services ResearchUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 91 Years
Eligibility Inclusion Criteria:

- Uncontrolled open angle glaucoma patients

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Procedure:
• Titanium Sapphire laser trabeculoplasty

Locations
Country Name City State
Israel Goldschleger Eye Institute Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
Goldschleger Eye Institute

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary IOP
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