Phacoemulsification vs SLT for Pseudoexfoliation Glaucoma

(CANPEX1 Trial)

Overseen By Marcelo Nicolela, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Must not be taking: Oral steroids

Disqualifiers: Age < 50, Angle closure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

200 Participants Needed

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}

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.

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
• Selective Laser Trabeculoplasty

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 European Union, United States, Canada for the following indications:

Approved in European Union as Phacoemulsification for:

• Cataract removal
• Glaucoma treatment

Approved in United States as Phacoemulsification for:

• Cataract removal
• Glaucoma treatment

Approved in Canada as Phacoemulsification for:

• Cataract removal
• Glaucoma treatment

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 of 74 glaucoma patients undergoing combined clear cornea phacoemulsification and Trabectome surgery, those who had prior Selective Laser Trabeculoplasty (SLT) showed significant reductions in intraocular pressure (IOP) at six months, particularly in patients with Pseudoexfoliation Glaucoma (46% decrease) and Pigmentary Glaucoma (38% decrease).

The results suggest that prior SLT treatment does not negatively impact surgical outcomes and may even enhance the effectiveness of the Trabectome procedure, especially in patients with PEX and PG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Selective Laser Trabeculoplasty (SLT) on combined clear cornea phacoemulsification and Trabectome outcomes. Klamann, MK., Gonnermann, J., Maier, AK., et al.[2021]

Selective laser trabeculoplasty (SLT) can be an effective option for managing intraocular pressure (IOP) in patients with glaucoma who have previously undergone failed phacoemulsification cataract extraction combined with excimer laser trabeculotomy, as it may help slow disease progression.

However, the median time to failure after SLT is relatively short at 7.2 months, indicating that patients will require close monitoring and may need to consider incisional surgery if IOP control is not maintained.

NCBI (Pubmed)

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. Krzyzanowska, I., Ziegler, J., Meier-Gibbons, F., et al.[2022]

In a study of 14 eyes from 13 patients who underwent selective laser trabeculoplasty (SLT) after failed phacoemulsification cataract extraction combined with ab interno trabeculectomy, SLT did not successfully lower intraocular pressure (IOP) in any cases, indicating a lack of efficacy in this context.

The median time to failure for SLT was only 3.6 months, and there was no change in the number of antiglaucoma medications used, suggesting that alternative treatments, like incisional filtration surgery, may be more effective options after a failed phaco-trabectome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective laser trabeculoplasty following failed combined phacoemulsification cataract extraction and ab interno trabeculectomy. Töteberg-Harms, M., Rhee, DJ.[2013]

A study comparing argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT) in 207 patients with pseudoexfoliation glaucoma found that both treatments effectively reduced intraocular pressure (IOP) without significant differences in outcomes over 24 months.

Both ALT and SLT showed similar reductions in IOP and the need for glaucoma medications, indicating that either laser treatment can be a viable option for managing PXE glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating selective laser trabeculoplasty versus argon laser trabeculoplasty in pseudoexfoliation glaucoma patients. Song, JSA., Vianna, J., Shuba, L., et al.[2022]

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]

Selective laser trabeculoplasty (SLT) significantly lowers intraocular pressure (IOP) more effectively in patients with pseudoexfoliative glaucoma (PXG) compared to those with primary open-angle glaucoma (POAG), with mean decreases of -6.1 mmHg and -4.4 mmHg respectively over a 1-year follow-up.

The safety profile of SLT is similar for both types of glaucoma, as the rates of side effects like early IOP spikes and uveitis did not significantly differ between the POAG and PXG groups.

NCBI (Pubmed)

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. Kara, N., Altan, C., Yuksel, K., et al.[2013]

Selective laser trabeculoplasty (SLT) significantly reduced intra-ocular pressure (IOP) in patients with uncontrolled pseudoexfoliation glaucoma, with a mean decrease of 31.5% from 26.01 mm Hg to 17.8 mm Hg after one year.

While SLT is generally safe, with most complications being mild (like conjunctival redness), there was a temporary increase in IOP in 3.5% of patients, which resolved quickly with treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective laser trabeculoplasty in uncontrolled pseudoexfoliation glaucoma. Goldenfeld, M., Geyer, O., Segev, E., et al.[2019]

Selective laser trabeculoplasty (SLT) is particularly effective for steroid-induced glaucoma, showing a significant reduction in intraocular pressure and a lower treatment failure rate (54%) compared to pseudoexfoliative glaucoma (84%) and primary open-angle glaucoma (84%) over two years.

Patients with steroid-induced glaucoma also experienced a notable decrease in the need for ocular hypotensive medications after 18 months, while those with uveitic glaucoma increased their medication use, indicating differing responses to SLT among these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective laser trabeculoplasty in steroid-induced and uveitic glaucoma. Zhou, Y., Pruet, CM., Fang, C., et al.[2022]

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]