Status:
UNKNOWN
Comparing the Effectiveness of Phacoemulsification + ECP Laser and Phacoemulsification Alone for Glaucoma Patients
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
King's College London
Imperial College London
Conditions:
Glaucoma Open-Angle Primary
Cataract
Eligibility:
All Genders
40-85 years
Phase:
PHASE4
Brief 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 c...
Detailed Description
The study compares one off surgical interventions that are in routine clinical use and therefore there are no major ethical issues. All participants will be eligible for cataract surgery. Participants...
Eligibility Criteria
Inclusion
- General 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.
- Inclusion criteria for the study eye:
- 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).
- 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
- (in patients where the VF exam is not confirmatory for glaucomatous defect) OCT retinal nerve fibre layer imaging supporting the ophthalmoscopy findings indicating a diagnosis of mild glaucoma. (If OCT findings are not confirmatory of glaucoma and both the visual field and the OCT are normal, the patient should not be enrolled).
- Shaffer grade ≥2 in all four quadrants on gonioscopy.
- Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair surgical access to the ciliary processes.
Exclusion
- 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).
- Best corrected visual acuity worse than 6/36 in the fellow eye (i.e. not the eye undergoing the study intervention).
- A 24-2 SITA Standard Humphrey visual field mean deviation (MD) of worse than -12dB in the study eye.
- Previous vitreo-retinal surgery.
- Previous corneal surgery or clinically significant corneal dystrophy, e.g. Fuch's dystrophy (\>12 confluent guttae).
- Unclear ocular media preventing visualization of the fundus or anterior chamber angle.
- Degenerative visual disorders such as wet age-related macular degeneration.
- Clinically significant ocular pathology other than cataract and glaucoma.
- Clinically significant ocular inflammation or infection within 1 month prior to screening.
- Presence of extensive iris processes that obscure visualization of the trabecular meshwork.
- Uncontrolled systemic disease that in the opinion of the investigator would put the patient's health at risk and/or prevent the patient from completing all study visits.
- Current participation or participation within the past 30 calendar days in another investigational drug or device clinical trial (which includes the fellow eye).
- Pregnant or nursing women, or women of child bearing age planning pregnancy or not using medically acceptable contraceptives.
- Unwilling or unable to give informed consent/unwilling to accept randomisation.
- Unwilling or unable to return for scheduled protocol visits.
- Any inclusion criteria not met.
Key Trial Info
Start Date :
March 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 14 2023
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04295122
Start Date
March 15 2020
End Date
March 14 2023
Last Update
March 4 2020
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