Comparing the Effectiveness of Phacoemulsification + ECP Laser and Phacoemulsification Alone for … (NCT04295122) | Clinical Trial Compass
UnknownPhase 4
Comparing the Effectiveness of Phacoemulsification + ECP Laser and Phacoemulsification Alone for Glaucoma Patients
160 participantsStarted 2020-03-15
Plain-language summary
Laser endoscopic cyclophotocoagulation (ECP) has been in use for the treatment of glaucoma for over 20 years and is usually used in conjunction with cataract surgery. In the US it is one of the most commonly performed cataract 'plus' surgeries. The take-up of ECP laser has been much lower in the UK and Europe. This is partly due to the lack of robust clinical evidence from randomised controlled trials to justify its use in routine practice. More recently the advent of minimally invasive glaucoma surgery techniques (MIGS) has increased the options available for cataract 'plus' surgery. Without any randomised controlled trial data for the use of ECP laser in this context the increasingly popular use of MIGS devices, such as iStent (the current market leader) may further marginalise the use of ECP laser for cataract 'plus' surgery in patients with Primary Open Angle Glaucoma (POAG) and visually significant cataract.
To further evaluate the use of ECP laser for the treatment of glaucoma in patients with glaucoma and cataract, investigators plan to conduct a randomised controlled trial comparing cataract surgery alone versus cataract surgery plus ECP laser surgery. Investigators will compare the efficacy of these interventions for the treatment of glaucoma based on clinical outcomes and also undertake a cost-benefit analysis, taking into account the cost of surgery, any reduction in clinical time allocation for procedures, the frequency of intra- and post-operative complications, and any reduction in the need for topical glaucoma treatments post-surgery, as well as the frequency with which further glaucoma filtering surgery is needed for patients in each group.
Investigators anticipate that a total number of 160 patients (80 in each arm) will be adequate to detect whether there is any difference in efficacy between cataract surgery + ECP versus cataract surgery alone. Recruitment is expected to take around 9-12 months. Participants will undergo treatment wash-out (28 days minimum) of any eye drops they use for their glaucoma prior to data collection at baseline (before surgery) and prior to data collection at one-year and at two-years post-surgery. Results will be reviewed during an interim analysis at 6 months once 50 patients have reached that time point.
Who can participate
Age range
40 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female patients, from 40 to 85 years of age, inclusive.
. Patient is able and willing to attend scheduled follow-up examinations as per routine care for 2 year post-operatively.
. Patient is able to understand the information sheet and give informed consent.
. An operable age-related cataract with BCVA of 6/9 or worse that is eligible for phacoemulsification.
. A diagnosis of POAG or pigmentary glaucoma treated with hypotensive medications (eye drops for glaucoma).
. A previously documented unmedicated intraocular pressure of \> 21 mmHg (i.e. IOP \> 21 mmHg prior to the commencement of glaucoma treatment).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. An optic nerve appearance characteristic of glaucoma with either:
. visual field loss (no worse than -12dB) identified on examination using Humphrey 24-2 SITA standard, or
Exclusion criteria
. Diagnosis of Primary angle closure glaucoma.
. Any diabetic retinopathy.
. Previous history of Central Serous Retinopathy or Cystoid Macular Oedema in either eye.
. Congenital or developmental glaucoma.
. Secondary glaucoma (such as neovascular, uveitic, pseudoexfoliative, lens-induced, steroid-induced, trauma induced, or glaucoma associated with increased episcleral venous pressure).
. Previous trabeculectomy, tube shunts, or any other prior subconjunctival filtration or cycloderstructive surgery.
. Inability to complete a reliable 24-2 SITA Standard Humphrey visual field on the study eye at screening (fixation losses, false positive errors and false negative errors should not be greater than 33%).
. Patients with advanced glaucoma or any patient where the risk to the patient of a washout of ocular hypotensive medications (eye drops for glaucoma) is assessed as unacceptable (i.e. where there may be a risk of damage to vision if treatment is stopped for the washout).