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NCT Number: NCT04416724

Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma

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.

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Key information

Conditions

Pseudoexfoliation Glaucoma Exfoliation Syndrome Eye Diseases Iris Diseases Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Scotia Health

Halifax, Nova Scotia, B3H 2Y9, Canada

Location status: Recruiting

Location contact

Marcelo Nicolela, MD

CONTACT

[email protected]

902-473-2839

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pseudoexfoliation syndrome, detected at slit-lamp examination by exfoliative material on anterior capsule, pupil, or anterior chamber angle
  • 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
  • Presence of asymptomatic early cataract

Exclusion criteria

  • Age less than 50 years old
  • Anterior chamber angle closure at gonioscopy, defined as pigmented trabeculum visible in less than 180º
  • Previous IOP lowering procedure such as trabeculoplasty, trabeculectomy, or minimally invasive glaucoma surgery
  • Previous use of IOP lowering medication for more than 6 months
  • 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
  • IOP at baseline visit higher than 36 mmHg
  • Visual field damage at baseline visit with mean deviation worse than -15 dB
  • Not able or willing to provide voluntary, informed consent to participate in the study

Treatment and study plan

phacoemulsification

Procedure

Lens removal by Phacoemulsification

Selective laser trabeculoplasty

Device

Laser application in trabecular meshwork

Primary outcomes

  1. Medication-free intraocular pressure control

    Time frame: 2 years

    Proportion of subjects without use of intraocular pressure lowering medications

Secondary outcomes

  1. Medication-free intraocular pressure control

    Time frame: 10 years

    Proportion of subjects without use of intraocular pressure lowering medications

  2. Intraocular pressure change from baseline

    Time frame: 10 years

  3. Number of intraocular pressure lowering medications

    Time frame: 10 years

  4. Time to introduction of intraocular pressure lowering medications

    Time frame: 10 years

  5. Number of adverse effects

    Time frame: 10 years

  6. Score at the Glaucoma Quality of Life - 15

    Time frame: 10 years

    The questionnaire GQL-15 was described in PMID: 12671469. The minimum value is 15 and the maximum is 75, with lower values indicating better quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Marcelo Nicolela, MD

CONTACT

[email protected]

902-473-2839

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • Canadian Glaucoma Society
  • Glaucoma Research Society of Canada

Registry information

Official study title

Canadian Pseudoexfoliation Glaucoma Trial: Comparison of Phacoemulsification Versus Selective Laser Trabeculoplasty as Initial Treatment for Pseudoexfoliation Glaucoma

Acronym: CANPEX1

Important dates

Study start
2022
Primary completion
2025
Study completion
2033
First posted
Jun 4, 2020
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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