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Selective Laser Trabeculoplasty After Failed Phacoemulsification With Eximer Laser Trabeculectomy (SLT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02434250
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
The aim of this study is to evaluate the efficacy of selective laser trabeculoplasty after a prior failed phacoemulsification and Eximer Laser Trabeculectomy.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Cataract Procedure: Selective Laser Trabeculoplasty Not Applicable

Detailed Description:
This study evaluates the efficacy of selective laser trabeculoplasty after a failed combined procedure of phacoemulsification cataract extraction with intraocular lens implantation plus Eximer Laser Trabeculectomy in open angle glaucoma or ocular hypertension. The success of SLT will be determined by the intraocular pressure and number of hypotensive drugs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Selective Laser Trabeculoplasty (SLT) After Failed Phacoemulsification Cataract Extraction Combined With Eximer Laser Trabeculectomy (Phaco-ELT) in Open Angle Glaucoma and Ocular Hypertension
Study Start Date : May 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016


Arm Intervention/treatment
Experimental: SLT arm
Patient receiving 'Selective Laser Trabeculoplasty' (SLT) due to failed Phacoemulsification Cataract Extraction with Intraocular Lens Implantation combined with Eximer Laser Trabeculectomy (phaco-ELT) in Open Angle Glaucoma and Ocular Hypertension to control intraocular pressure and/or glaucoma progression.
Procedure: Selective Laser Trabeculoplasty
Selective Laser Trabeculoplasty is a laser treatment procedure to enhance trabecular aequous humor outflow and thus decrease intraocular pressure.




Primary Outcome Measures :
  1. Efficacy intraocular pressure [ Time Frame: t0 and t=12 month ]
    Efficacy as measured by decrease in intraocular pressure from baseline

  2. Efficacy medication [ Time Frame: t0 and t=12 month ]
    as measured by decrease in number of used hypotensive medications


Secondary Outcome Measures :
  1. Efficacy visual acuity [ Time Frame: t0 and t=12 month ]
    Efficacy as increase in best corrected visual acuity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of open angle glaucoma or ocular hypertension
  • and diagnosis of cataract

Exclusion Criteria:

  • diagnosis of angle closure glaucoma
  • any optic neuropathy other than glaucoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434250


Locations
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Switzerland
Department of Ophthalmology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Marc Toeteberg-Harms, MD, FEBO UniversityHospital Zurich, Dept. of Ophthalmology
Additional Information:
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02434250    
Other Study ID Numbers: SLT after Phaco-ELT
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
Open angle glaucoma
Ocular hypertension
Cataract
Selective Laser Trabeculoplasty
Eximer Laser Trabeculectomy
Phacoemulsification Cataract Extraction
Additional relevant MeSH terms:
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Glaucoma
Cataract
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Lens Diseases