aser treatment versus eye drops as initial treatment in exfoliation glaucoma

Phase 1

• Conditions: Glaucoma; MedDRA version: 20.0Level: LLTClassification code 10037118Term: Pseudoexfoliation glaucomaSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2019-004841-34-FI
• Lead Sponsor: Mika Harju

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-25
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

age of 50 –100 years, possibility to attend period of 12 months, exfoliation, newly diagnosed exfoliation glaucoma by EGS (European glaucoma society) guidelines or ocular hypertensio TA 24 mmHg or more, eye pressure less than 35 mmHg.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 82

Exclusion Criteria

advanced glaucoma, target IOP less than 15, starting eye pressure 35 or more, eye vision 0.2 or worse, angle closure, unable to use eye drops, significant cataract, other active eye disease, previous intraocular operation excluding uncomplicated cataract surgery 1 year ago or earlier, clinical significant macular edema, intraocular injections to wet AMD, proliferative diabetic retinopathy, intraocular tumor, IOL luxation, active uveitis, serious other medical condition, participating in other clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the trial is to show the equilance in efficacy of SLT laser treatment compared to medical therapy as a primary therapy in exfoliation glaucoma.;Secondary Objective: Not applicable;Primary end point(s): Primary end point is enhancement of treatment by adding eye drops.<br>;Timepoint(s) of evaluation of this end point: 12 months from the beginning of the treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary end points are eye dryness and eye pressure and long term end points are cumulative success of SLT-treatment and need for glaucoma surgery.;Timepoint(s) of evaluation of this end point: 12 months and long term evaluation up to 10 years.