Recruiting

Phacoemulsification vs. SLT

Sponsor:

Nova Scotia Health Authority

Code:

NCT04416724

Conditions

Pseudoexfoliation Glaucoma

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Phacoemulsification

Selective Laser Trabeculoplasty

Study Details

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.

Conditions

Pseudoexfoliation Glaucoma

Study ID

NCT04416724

Start date

Oct 10, 2022

Status verified date

Aug, 2024

Completion date

Aug, 2033

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 180ยบ
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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phacoemulsification

Main study intervention will be Phacoemulsification

experimental: SLT

Main study intervention will be Selective Laser Trabeculoplasty

Interventions

Phacoemulsification

Lens removal by Phacoemulsification

Selective Laser Trabeculoplasty

Laser application in trabecular meshwork

Primary outcome measure

  • Medication-free intraocular pressure control [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Marcelo Nicolela, MD

902-473-2839nicolela@dal.ca

Locations

Nova Scotia Health

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contacts

Marcelo Nicolela, MD

902-473-2839nicolela@dal.ca

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Aug 21, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2024-08-21.