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QoL Assessment in Traditional Glaucoma Surgery and MIGS.

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ClinicalTrials.gov Identifier: NCT03613233
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Marek Rekas, Military Institute of Medicine, Poland

Brief Summary:
Quality of Life assessment before and after various glaucoma surgery (traditional and microinvasive (MIGS)).

Condition or disease Intervention/treatment Phase
Glaucoma Procedure: Glaucoma surgery Not Applicable

Detailed Description:
Patients qualified for glaucoma surgical procedure fill in QoL questionnaire (NEI VFQ 25) at baseline (pre-operatively) and 3 months after glaucoma surgery. Additional data will be collected such as demographic data and medical data, visual acuity, intraocular pressure, number of glaucoma medications, stage of glaucoma based on visual field assessment, medical ophthalmic history, intra and postoperative complications, postoperative interventions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Quality of Life Assessment in Traditional and Microinvasive Glaucoma Surgery.
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: traditional glaucoma surgery
glaucoma procedures such as trabeculectomy, iridencleisis, non - penetrating deep sclerectomy
Procedure: Glaucoma surgery
phacoemulsification
Other Name: cataract surgery when required

Active Comparator: microinvasive glaucoma surgery (MIGS)
glaucoma procedures such as : canaloplasty (traditional, ABiC, modified), iStent, XEN, Cypass,Hydrus- and with any other microinvasive IOP reducing device
Procedure: Glaucoma surgery
phacoemulsification
Other Name: cataract surgery when required




Primary Outcome Measures :
  1. NEI VFQ 25 quality of life score change [ Time Frame: baseline (0-30 days; pre-operative) and three months after surgery ]
    NEI VFQ 25 baseline and 3 months after surgery



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:

patients qualified for glaucoma surgery in Military Institute of Medicine - based on following Inclusion Criteria:

  • all glaucoma types with characteristic glaucoma changes (biomicroscopic ,visual field) with documented glaucoma progression
  • patients not tolerating antiglaucoma medications,
  • patients with poor compliance
  • progression in visual field

Exclusion Criteria:

  • active inflammatory disease
  • pregnancy
  • mental disease or emotional instability
  • general steroid therapy
  • inability to fill in the questionnaire

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): NCT03613233


Contacts
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Contact: Anna Byszewska, MD, PhD 500285890 ext 48 ania.byszewska@gmail.com
Contact: Marek Rękas, prof.; MD; PhD mrekas@wim.mil.pl

Locations
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Poland
Military Institute of Medicine Recruiting
Warsaw, Poland, 04-141
Contact: Anna Byszewska, MD,PhD    500285890 ext 48    ania.byszewska@gmail.com   
Sponsors and Collaborators
Military Institute of Medicine, Poland

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Responsible Party: Marek Rekas, płk prof. Marek RĘKAS, MD, PhD, Military Institute of Medicine, Poland
ClinicalTrials.gov Identifier: NCT03613233     History of Changes
Other Study ID Numbers: 0000000417
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Marek Rekas, Military Institute of Medicine, Poland:
MIGS
canaloplasty
glaucoma
glaucoma surgery
glaucoma implant
deep sclerectomy
iridencleisis
QoL
quality of life
NEI VFQ 25

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases