Phacoemulsification vs SLT for Pseudoexfoliation Glaucoma

(CANPEX1 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Nova Scotia Health Authority

Must not be taking: Oral steroids

Disqualifiers: Age < 50, Angle closure, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have been using IOP lowering medication for more than 6 months, you cannot participate in the trial.

What data supports the effectiveness of the treatment Phacoemulsification and Selective Laser Trabeculoplasty (SLT) for Pseudoexfoliation Glaucoma?

Research shows that Selective Laser Trabeculoplasty (SLT) can effectively reduce eye pressure in different types of glaucoma, including Pseudoexfoliation Glaucoma. Additionally, SLT has been shown to help control eye pressure after other eye surgeries, suggesting it may be beneficial in managing Pseudoexfoliation Glaucoma. ^{1 2 3 4 5}

Is phacoemulsification and SLT safe for treating pseudoexfoliation glaucoma?

Research shows that Selective Laser Trabeculoplasty (SLT) is generally safe for treating pseudoexfoliation glaucoma, with studies focusing on its safety and effectiveness in lowering eye pressure. Phacoemulsification, a type of cataract surgery, is also widely used and considered safe, though specific safety data for its use in pseudoexfoliation glaucoma is not detailed in the available studies. ^{1 2 3 6 7}

How does the treatment of Phacoemulsification and SLT differ from other treatments for pseudoexfoliation glaucoma?

Phacoemulsification (a type of cataract surgery) combined with Selective Laser Trabeculoplasty (SLT) offers a unique approach by addressing both cataract removal and reducing eye pressure, which is crucial for managing pseudoexfoliation glaucoma. This combination is distinct because it targets both the lens and the drainage system of the eye, potentially providing a more comprehensive treatment compared to other methods that may focus on only one aspect. ^{1 2 4 5 8}

Research Team

Eligibility Criteria

This trial is for patients with pseudoexfoliation syndrome, which can be seen during an eye exam. They should need treatment to lower their eye pressure and have an early cataract without symptoms. People who don't meet these specific eye conditions or require different treatments are not eligible.

Inclusion Criteria

I have been diagnosed with pseudoexfoliation syndrome.

My doctor thinks I need treatment to lower my eye pressure.

I have an early-stage cataract without symptoms.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either Selective Laser Trabeculoplasty (SLT) or Phacoemulsification (PHACO) to lower intraocular pressure

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on intraocular pressure control and visual function

2 years

Long-term follow-up

Chart review to obtain longer follow-up information beyond two years, conducted 5 and 10 years after randomization

10 years

Treatment Details

Interventions

• Phacoemulsification (Surgery)
• Selective Laser Trabeculoplasty (Laser Therapy)

Trial Overview The study compares two initial treatments for lowering eye pressure in pseudoexfoliation glaucoma: Selective Laser Trabeculoplasty (SLT) and Phacoemulsification (PHACO). Patients will be randomly assigned to one of the treatments and followed for 2 years, with some monitored up to 10 years.

Participant Groups

Group I: SLT Experimental Treatment 1 Intervention

Main study intervention will be Selective Laser Trabeculoplasty

Group II: Phacoemulsification Experimental Treatment 1 Intervention

Main study intervention will be Phacoemulsification

Phacoemulsification is already approved in Canada for the following indications:

Approved in Canada as Phacoemulsification for:

• Cataract removal
• Glaucoma treatment

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Nova Scotia Health Halifax, Canada

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Jayme Vianna

Lead Sponsor

Trials

1

Recruited

200+

Glaucoma Research Society of Canada

Collaborator

Trials

8

Recruited

1,300+

Canadian Glaucoma Society

Collaborator

Trials

1

Recruited

200+

Findings from Research

In a study involving 46 patients (20 with pseudoexfoliative glaucoma and 28 with primary open angle glaucoma), 360-degree selective laser trabeculoplasty (SLT) effectively reduced intraocular pressure (IOP) without requiring additional medications, demonstrating its safety and efficacy as a treatment option.

The success rate of IOP reduction was higher in the pseudoexfoliative glaucoma group (94.1% at 6 months) compared to the primary open angle glaucoma group (75% at 6 months), although both groups showed similar outcomes at the 12-month follow-up, indicating that the initial response may vary between the two types of glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective laser trabeculoplasty in patients with pseudoexfoliative glaucoma vs primary open angle glaucoma: a one-year comparative study. Miraftabi, A., Nilforushan, N., Nassiri, N., et al.[2020]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Influence of Selective Laser Trabeculoplasty (SLT) on combined clear cornea phacoemulsification and Trabectome outcomes. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Selective laser trabeculoplasty following failed combined phacoemulsification cataract extraction and excimer laser trabeculotomy can control intraocular pressure for a limited time. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Selective laser trabeculoplasty following failed combined phacoemulsification cataract extraction and ab interno trabeculectomy. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Evaluating selective laser trabeculoplasty versus argon laser trabeculoplasty in pseudoexfoliation glaucoma patients. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Selective laser trabeculoplasty in patients with pseudoexfoliative glaucoma vs primary open angle glaucoma: a one-year comparative study. [2020]

6. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy and safety of selective laser trabeculoplasty in cases with primary open-angle glaucoma and pseudoexfoliative glaucoma. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Selective laser trabeculoplasty in uncontrolled pseudoexfoliation glaucoma. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Selective laser trabeculoplasty in steroid-induced and uveitic glaucoma. [2022]