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OpenTrials
Completed

NCT Number: NCT00470964

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

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

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Key information

Age range

40 year–91 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goldschleger Eye Institute

Ramat Gan, 52621, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Uncontrolled open angle glaucoma patients

Treatment and study plan

Titanium Sapphire laser trabeculoplasty

Procedure

Primary outcomes

  1. IOP

Sponsors and collaborators

Lead sponsor

Goldschleger Eye Institute

Other

Registry information

Important dates

First posted
May 8, 2007
Registry last updated
May 8, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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