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Comparing the Effectiveness of Phacoemulsification + ECP Laser and Phacoemulsification Alone for Glaucoma Patients (CONCEPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04295122
Recruitment Status : Not yet recruiting
First Posted : March 4, 2020
Last Update Posted : March 4, 2020
Sponsor:
Collaborators:
King's College London
Imperial College London
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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 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.


Condition or disease Intervention/treatment Phase
Glaucoma Open-Angle Primary Cataract Device: Phacoemulsification+ Endoscopic cyclophotocoagulation (ECP) laser Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparing the Effectiveness of Phacoemulsification + ECP Laser and Phacoemulsification Alone for the Treatment of Open Angle Glaucoma in Patients With Cataract - a Randomised Controlled Trial
Estimated Study Start Date : March 15, 2020
Estimated Primary Completion Date : March 14, 2022
Estimated Study Completion Date : March 14, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

Arm Intervention/treatment
Active Comparator: Phacoemulsification + ECP laser

Cataract surgery will be performed using standard anesthesia and phacoemulsification techniques. A clear corneal incision should be used for instrumentation. The choice of viscoelastics to maintain the anterior chamber is left to the surgeon's discretion. The viscoelastic will be washed-out of the capsular bag after IOL insertion. Further cohesive viscoelastic material will be injected through the main wound between the anterior capsule and iris, until the iris is close to or touching the cornea. A curved ECP probe will be inserted through the corneal incision wound/wounds and 360° of the anterior section of the ciliary processes will be treated. The power setting will be varied according to tissue response (starting power of 250 mW with continuous setting). 'Pops' should be avoided (but recorded) but no indentation used during treatment.

Intracameral cefuroxime and dexamethasone will be injected into the anterior chamber and sutures used to close the incisions as required.

Device: Phacoemulsification+ Endoscopic cyclophotocoagulation (ECP) laser

A clear corneal incision should be used for instrumentation. The choice of viscoelastics to maintain the anterior chamber is left to the surgeon's discretion.

Phacoemulsification energy used during the cataract surgery will be recorded. If the patient has been randomised to ECP laser, the viscoelastic will be washed-out of the capsular bag. Further cohesive viscoelastic material will be injected through the main wound between the anterior capsule and iris, until the iris is close to or touching the cornea. A curved ECP probe will be inserted through the corneal incision wound/wounds and 360° of the anterior section of the ciliary processes will be treated. The power setting will be varied according to tissue response (starting power of 250 mW with continuous setting). 'Pops' should be avoided (but recorded) but no indentation used during treatment. Final power used and duration of surgery will be recorded.


Active Comparator: Phacoemulsification alone
Cataract surgery will be performed using standard anesthesia and phacoemulsification techniques. A clear corneal incision should be used for instrumentation. The choice of viscoelastics to maintain the anterior chamber is left to the surgeon's discretion. For this study, monofocal IOLs are required.
Device: Phacoemulsification+ Endoscopic cyclophotocoagulation (ECP) laser

A clear corneal incision should be used for instrumentation. The choice of viscoelastics to maintain the anterior chamber is left to the surgeon's discretion.

Phacoemulsification energy used during the cataract surgery will be recorded. If the patient has been randomised to ECP laser, the viscoelastic will be washed-out of the capsular bag. Further cohesive viscoelastic material will be injected through the main wound between the anterior capsule and iris, until the iris is close to or touching the cornea. A curved ECP probe will be inserted through the corneal incision wound/wounds and 360° of the anterior section of the ciliary processes will be treated. The power setting will be varied according to tissue response (starting power of 250 mW with continuous setting). 'Pops' should be avoided (but recorded) but no indentation used during treatment. Final power used and duration of surgery will be recorded.





Primary Outcome Measures :
  1. Change in post-washout IOP at 24 months [ Time Frame: Two years ]
    Change in post-washout IOP of at least 2.7 mmHg at 24 months from baseline. The IOP will be measured using Goldmann applanation tonometer at each visit.


Secondary Outcome Measures :
  1. The percentage of IOP reduction [ Time Frame: Two years ]
    The % of patients with reduction of mean diurnal IOP of ≥ 20% from baseline at 24 months following medication washout.The IOP will be measured using Goldmann applanation tonometer at 9 am and 11 am at baseline, 12 and 24 months follow up visits. Mean diurnal IOP will be calculated using statistics package.

  2. Change in number of glaucoma medication used [ Time Frame: Two years ]
    Change in number of glaucoma medication used at 24 months from baseline.

  3. Cost effectiveness [ Time Frame: Two years ]

    Time reductions - If using ECP as the new standard of care (instead of drainage surgery), time reductions operatively will allow for more surgical procedures to be performed in theatres, which will benefit NHS Trusts.

    Change in number of glaucoma therapeutic drugs - Cost savings can be naturally made if the surgical procedure is sustainable over a period of 2 years. Clinic, GP and pharmacy visits required will be assessed using patient questionnaire.


  4. Intra- and Post-operative complication rates [ Time Frame: Two years ]
    Rate of complications will be recorded and compared between two groups. Safety outcomes include: Loss of > 2 lines of BCVA, slit lamp and fundus examination findings, the incidence of complications and adverse events.



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

General inclusion criteria:

  1. Male and female patients, from 40 to 85 years of age, inclusive.
  2. Patient is able and willing to attend scheduled follow-up examinations as per routine care for 2 year post-operatively.
  3. Patient is able to understand the information sheet and give informed consent.

    Inclusion criteria for the study eye:

  4. An operable age-related cataract with BCVA of 6/9 or worse that is eligible for phacoemulsification.
  5. A diagnosis of POAG or pigmentary glaucoma treated with hypotensive medications (eye drops for glaucoma).
  6. A previously documented unmedicated intraocular pressure of > 21 mmHg (i.e. IOP > 21 mmHg prior to the commencement of glaucoma treatment).
  7. An optic nerve appearance characteristic of glaucoma with either:

    1. visual field loss (no worse than -12dB) identified on examination using Humphrey 24-2 SITA standard, or
    2. (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).
  8. Shaffer grade ≥2 in all four quadrants on gonioscopy.
  9. Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair surgical access to the ciliary processes.

Exclusion Criteria:

  1. Diagnosis of Primary angle closure glaucoma.
  2. Any diabetic retinopathy.
  3. Previous history of Central Serous Retinopathy or Cystoid Macular Oedema in either eye.
  4. Congenital or developmental glaucoma.
  5. Secondary glaucoma (such as neovascular, uveitic, pseudoexfoliative, lens-induced, steroid-induced, trauma induced, or glaucoma associated with increased episcleral venous pressure).
  6. Previous trabeculectomy, tube shunts, or any other prior subconjunctival filtration or cycloderstructive surgery.
  7. 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%).
  8. 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).
  9. Best corrected visual acuity worse than 6/36 in the fellow eye (i.e. not the eye undergoing the study intervention).
  10. A 24-2 SITA Standard Humphrey visual field mean deviation (MD) of worse than -12dB in the study eye.
  11. Previous vitreo-retinal surgery.
  12. Previous corneal surgery or clinically significant corneal dystrophy, e.g. Fuch's dystrophy (>12 confluent guttae).
  13. Unclear ocular media preventing visualization of the fundus or anterior chamber angle.
  14. Degenerative visual disorders such as wet age-related macular degeneration.
  15. Clinically significant ocular pathology other than cataract and glaucoma.
  16. Clinically significant ocular inflammation or infection within 1 month prior to screening.
  17. Presence of extensive iris processes that obscure visualization of the trabecular meshwork.
  18. 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.
  19. Current participation or participation within the past 30 calendar days in another investigational drug or device clinical trial (which includes the fellow eye).
  20. Pregnant or nursing women, or women of child bearing age planning pregnancy or not using medically acceptable contraceptives.
  21. Unwilling or unable to give informed consent/unwilling to accept randomisation.
  22. Unwilling or unable to return for scheduled protocol visits.
  23. Any inclusion criteria not met.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04295122


Contacts
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Contact: Lina Danieliute, MSc, PGCert 02071884885 lina.danieliute@gstt.nhs.uk
Contact: Sheng Lim, MD, FRCOphth sheng.lim@gstt.nhs.uk

Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
Imperial College London
Publications:

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04295122    
Other Study ID Numbers: 263262
First Posted: March 4, 2020    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Glaucoma
Cataract
ECP laser
Additional relevant MeSH terms:
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Glaucoma
Cataract
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Lens Diseases