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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Glaucoma, Cataract

Intervention / Treatment
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* Procedure: phaco
* Procedure: phaco-ELT
* Procedure: phaco-Trabectome


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| phaco alone<br>patients w/ diagnosis of open angle glaucoma underwent phaco alone | Procedure: phaco<br>* Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) alone<br>|
| phaco-ELT<br>patients w/ diagnosis of open angle glaucoma underwent combined phaco plus ELT | Procedure: phaco<br>* Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) alone<br>Procedure: phaco-ELT<br>* Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) plus excimer laser trabeculotomy (ELT)<br>|
| phaco-Trabectome<br>patients w/ diagnosis of open angle glaucoma underwent combined phaco plus Trabectome | Procedure: phaco<br>* Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) alone<br>Procedure: phaco-Trabectome<br>* Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) plus Trabectome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, cataract