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Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma

Not Applicable
Recruiting
Conditions
Pseudoexfoliation Glaucoma
Registration Number
NCT04416724
Lead Sponsor
Nova Scotia Health Authority
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Inclusion Criteria:<br><br> 1. Pseudoexfoliation syndrome, detected at slit-lamp examination by exfoliative<br> material on anterior capsule, pupil, or anterior chamber angle<br><br> 2. Clinical decision to lower the IOP, as assessed by the investigator who is treating<br> the subject, based on the presence of PXG or with IOP elevated enough to warrant<br> treatment, even without clear evidence of optic nerve damage or visual field defect<br><br> 3. Presence of asymptomatic early cataract<br><br>Exclusion Criteria:<br><br> 1. Age less than 50 years old<br><br> 2. Anterior chamber angle closure at gonioscopy, defined as pigmented trabeculum<br> visible in less than 180º<br><br> 3. Previous IOP lowering procedure such as trabeculoplasty, trabeculectomy, or<br> minimally invasive glaucoma surgery<br><br> 4. Previous use of IOP lowering medication for more than 6 months<br><br> 5. Presence of ocular or systemic pathology or medication that could significantly<br> influence the IOP, such as: uveitis, neovascular or traumatic glaucoma, corneal<br> pathology influencing tonometry, use of oral steroids<br><br> 6. IOP at baseline visit higher than 36 mmHg<br><br> 7. Visual field damage at baseline visit with mean deviation worse than -15 dB<br><br> 8. Not able or willing to provide voluntary, informed consent to participate in the<br> study

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Medication-free intraocular pressure control
Secondary Outcome Measures
NameTimeMethod
Medication-free intraocular pressure control;Intraocular pressure change from baseline;Number of intraocular pressure lowering medications;Time to introduction of intraocular pressure lowering medications;Number of adverse effects;Score at the Glaucoma Quality of Life - 15
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