QoL Assessment in Traditional Glaucoma Surgery and MIGS.

NCT ID: NCT03613233

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-04-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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traditional glaucoma surgery

glaucoma procedures such as trabeculectomy, iridencleisis, non - penetrating deep sclerectomy

Group Type ACTIVE_COMPARATOR

Glaucoma surgery

Intervention Type PROCEDURE

phacoemulsification

microinvasive glaucoma surgery (MIGS)

glaucoma procedures such as : canaloplasty (traditional, ABiC, modified), iStent, XEN, Cypass,Hydrus- and with any other microinvasive IOP reducing device

Group Type ACTIVE_COMPARATOR

Glaucoma surgery

Intervention Type PROCEDURE

phacoemulsification

Interventions

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Glaucoma surgery

phacoemulsification

Intervention Type PROCEDURE

Other Intervention Names

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cataract surgery when required

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Military Institute od Medicine National Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Marek Rekas

płk prof. Marek RĘKAS, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Military Institute of Medicine

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Anna Byszewska, MD, PhD

Role: CONTACT

500285890 ext. 48

Marek Rękas, prof.; MD; PhD

Role: CONTACT

Facility Contacts

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Anna Byszewska, MD,PhD

Role: primary

500285890 ext. 48

Other Identifiers

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0000000417

Identifier Type: -

Identifier Source: org_study_id

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