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

Cataract Clinical Trial

Official title:

Longtime Efficiency of Combined Cataract-Surgery and Excimer-Laser-Trabeculotomy or Trabectome in Glaucoma Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194310
• Other study ID #: Phako/ELT/Trabectome-12m
• Status: Completed
• Phase: N/A
• First received: August 31, 2010
• Last updated: July 10, 2017
• Start date: January 1, 2009
• Est. completion date: December 31, 2016

Study information

• Verified date: July 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• All patients, which had Phaco, Phako/ELT, or Phaco-Trabectome from 01/2008 until 12/2011, where screened 12 month after surgery

Exclusion criteria:

• IOP >35 mmHg

Related Conditions & MeSH terms

• Cataract
• Glaucoma

Intervention

Procedure:
• phaco
Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) alone
• phaco-ELT
Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) plus excimer laser trabeculotomy (ELT)
• phaco-Trabectome
Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) plus Trabectome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland,