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

University of Zurich (UZH)

Status: Completed

Conditions: Cataract; Glaucoma

Treatments: Procedure: phaco-ELT; Procedure: phaco; Procedure: phaco-Trabectome

Study type: Observational

Funder types: Other

Identifiers

NCT01194310

Phako/ELT/Trabectome-12m

Details and patient eligibility

About

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.

Full 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

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

245 participants in 3 patient groups

phaco alone

Description:

patients w/ diagnosis of open angle glaucoma underwent phaco alone

Treatment:

Procedure: phaco

phaco-ELT

Description:

patients w/ diagnosis of open angle glaucoma underwent combined phaco plus ELT

Treatment:

Procedure: phaco-ELT

Procedure: phaco

phaco-Trabectome

Description:

patients w/ diagnosis of open angle glaucoma underwent combined phaco plus Trabectome

Treatment:

Procedure: phaco

Procedure: phaco-Trabectome