QoL Assessment in Traditional Glaucoma Surgery and MIGS.

Glaucoma Clinical Trial

Official title:

Quality of Life Assessment in Traditional and Microinvasive Glaucoma Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03613233
• Other study ID #: 0000000417
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: July 2018
• Source: Military Institute of Medicine, Poland
• Contact: Anna Byszewska, MD, PhD
• Phone: 500285890
• Email: ania.byszewska[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• Glaucoma surgery
phacoemulsification

Locations

Country	Name	City	State
Poland	Military Institute of Medicine	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Military Institute of Medicine, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NEI VFQ 25 quality of life score change	NEI VFQ 25 baseline and 3 months after surgery	baseline (0-30 days; pre-operative) and three months after surgery