Phaco vs. Phaco-ELT vs. Phaco-Trabectome 12m

Completed

• Conditions: Cataract; Glaucoma
• Interventions: Procedure: phaco; Procedure: phaco-ELT; Procedure: phaco-Trabectome

• Registration Number: NCT01194310
• Lead Sponsor: University of Zurich

Brief Summary

This study compares efficacy (i.e. IOP and hypotensive medications) of phaco alone vs. combined phaco plus excimer laser trabeculotomy vs. combined phaco plus trabectome.

Detailed Description

Glaucoma is one of the most common reasons for blindness. Usually an elevated drain resistance is the reason, while aqueous humor production is normal. Medical reduction of intraocular pressure (IOP) is first line therapy in most cases. The gold standard of surgical treatment still is trabeculectomy (TE) but TE has a lot of drawbacks. In particular when glaucoma and cataract coexists, the investigators therefore prefer the combined procedure cataract extraction plus excimer laser trabeculotomy (ELT) or plus Trabectome. Indication is cataract and a moderate elevated IOP without medical therapy or a moderate cataract and elevated IOP with medical therapy.

The ELT is performed by an AIDA XeCl-Excimer Laser System (TUI-Laser AG, Germering, 1,2 mJ per burst, burst duration 16 ns, wave length 308 nm, spot diameter 200 µm). 10 foramina were made over 90 degrees of the anterior chamber angle. Trabectome procedure is performed with the Trabectome unit from Neomedix.

* Trial with medical device

* Trial with surgical intervention

Study Timeline

• Study Start: 2009-01-01
• Study First Submitted: 2010-08-31
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-10
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
phaco alone	phaco	patients w/ diagnosis of open angle glaucoma underwent phaco alone
phaco-Trabectome	phaco	patients w/ diagnosis of open angle glaucoma underwent combined phaco plus Trabectome
phaco-ELT	phaco-ELT	patients w/ diagnosis of open angle glaucoma underwent combined phaco plus ELT
phaco-ELT	phaco	patients w/ diagnosis of open angle glaucoma underwent combined phaco plus ELT
phaco-Trabectome	phaco-Trabectome	patients w/ diagnosis of open angle glaucoma underwent combined phaco plus Trabectome