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

NCT ID: NCT01194310

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 245 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-01
• Study Completion Date: 2016-12-31

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

Conditions

Glaucoma; Cataract

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

phaco alone

patients w/ diagnosis of open angle glaucoma underwent phaco alone

phaco

Intervention Type: PROCEDURE

Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) alone

phaco-ELT

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

phaco

Intervention Type: PROCEDURE

Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) alone

phaco-ELT

Intervention Type: PROCEDURE

Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) plus excimer laser trabeculotomy (ELT)

phaco-Trabectome

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

phaco

Intervention Type: PROCEDURE

Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) alone

phaco-Trabectome

Intervention Type: PROCEDURE

Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) plus Trabectome

Interventions

phaco

Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) alone

Intervention Type: PROCEDURE

phaco-ELT

Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) plus excimer laser trabeculotomy (ELT)

Intervention Type: PROCEDURE

phaco-Trabectome

Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) plus Trabectome

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

01 Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Locations

Zurich, , Switzerland

Countries

Switzerland

References

Toteberg-Harms M, Hanson JV, Funk J. Cataract surgery combined with excimer laser trabeculotomy to lower intraocular pressure: effectiveness dependent on preoperative IOP. BMC Ophthalmol. 2013 Jun 24;13:24. doi: 10.1186/1471-2415-13-24.

Reference Type: DERIVED

PMID: 23799932 (View on PubMed)

Other Identifiers

Phako/ELT/Trabectome-12m

Identifier Type: -

Identifier Source: org_study_id