QoL Assessment in Traditional Glaucoma Surgery and MIGS.

July 29, 2018 updated by: Marek Rekas, Military Institute of Medicine, Poland

Quality of Life Assessment in Traditional and Microinvasive Glaucoma Surgery.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Warsaw, Poland, 04-141
        • Recruiting
        • Military Institute of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: traditional glaucoma surgery
glaucoma procedures such as trabeculectomy, iridencleisis, non - penetrating deep sclerectomy
Procedure: Glaucoma surgery
phacoemulsification
Other Names:
  • 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 Names:
  • cataract surgery when required

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline (0-30 days; pre-operative) and three months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Military Institute of Medicine, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

June 29, 2018

First Submitted That Met QC Criteria

July 29, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

July 29, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000000417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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