Clinical trial NCT04416724: Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma
Official title: Canadian Pseudoexfoliation Glaucoma Trial: Comparison of Phacoemulsification Versus Selective Laser Trabeculoplasty as Initial Treatment for Pseudoexfoliation Glaucoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pseudoexfoliation Glaucoma
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Glaucoma Research Society of Canada
name: Canadian Glaucoma Society
First posted: 2020-06-04
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Canadian Pseudoexfoliation Glaucoma Study 1 is a randomized clinical trial that aims to compare two initial treatment options - Selective Laser Trabeculoplasty (SLT) and Phacoemulsification (PHACO) - in newly diagnosed patients with pseudoexfoliation and need to lower the intraocular pressure. Patients with pseudoexfoliation and a recent decision to lower the intraocular pressure, who also have early asymptomatic lens opacification will be recruited and randomized to receive either SLT or PHACO. Patients will be followed for 2 years according to a target IOP protocol based on the Canadian Ophthalmological Society Glaucoma guidelines. Patients who do not achieve the target IOP with the initial randomization procedure will receive IOP lowering medications. The main outcome of interest will be the proportion of subjects who need IOP lowering medications after 2 years. Secondary outcomes include IOP reduction, time to need medications, patient reported outcomes in terms of visual function, and occurrence of adverse effects. To obtain longer follow-up information beyond two years, a chart review will be done 5 and 10 years after randomization.


Eligibility criteria: Inclusion Criteria:

1. Pseudoexfoliation syndrome, detected at slit-lamp examination by exfoliative material on anterior capsule, pupil, or anterior chamber angle
2. Clinical decision to lower the IOP, as assessed by the investigator who is treating the subject, based on the presence of PXG or with IOP elevated enough to warrant treatment, even without clear evidence of optic nerve damage or visual field defect
3. Presence of asymptomatic early cataract

Exclusion Criteria:

1. Age less than 50 years old
2. Anterior chamber angle closure at gonioscopy, defined as pigmented trabeculum visible in less than 180º
3. Previous IOP lowering procedure such as trabeculoplasty, trabeculectomy, or minimally invasive glaucoma surgery
4. Previous use of IOP lowering medication for more than 6 months
5. Presence of ocular or systemic pathology or medication that could significantly influence the IOP, such as: uveitis, neovascular or traumatic glaucoma, corneal pathology influencing tonometry, use of oral steroids
6. IOP at baseline visit higher than 36 mmHg
7. Visual field damage at baseline visit with mean deviation worse than -15 dB
8. Not able or willing to provide voluntary, informed consent to participate in the study

Primary outcomes:
measure: Medication-free intraocular pressure control
timeFrame: 2 years
Secondary outcomes:
measure: Medication-free intraocular pressure control
timeFrame: 10 years
measure: Intraocular pressure change from baseline
timeFrame: 10 years
measure: Number of intraocular pressure lowering medications
timeFrame: 10 years
measure: Time to introduction of intraocular pressure lowering medications
timeFrame: 10 years
measure: Number of adverse effects
timeFrame: 10 years
measure: Score at the Glaucoma Quality of Life - 15
timeFrame: 10 years
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health
state: Nova Scotia
Study officials:
References: