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

NCT04295122 | Unknown Phase 4 DMC

• 1 other identifier: 263262
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glaucoma Open-Angle Primary; Cataract

Keywords

Glaucoma; Cataract; ECP laser

Outcome Measures

Primary Outcomes (1)

• Change in post-washout IOP at 24 months

  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.

  Two years

Secondary Outcomes (4)

• The percentage of IOP reduction

  Two years

• Change in number of glaucoma medication used

  Two years

• Cost effectiveness

  Two years

• Intra- and Post-operative complication rates

  Two years

Study Arms (2)

Phacoemulsification + ECP laser

ACTIVE COMPARATOR

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

Phacoemulsification alone

ACTIVE COMPARATOR

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

Interventions

Phacoemulsification+ Endoscopic cyclophotocoagulation (ECP) laser DEVICE

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.

Phacoemulsification + ECP laser; Phacoemulsification alone

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator
• Imperial College London: collaborator

Related Publications (12)

• The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration.The AGIS Investigators. Am J Ophthalmol. 2000 Oct;130(4):429-40. doi: 10.1016/s0002-9394(00)00538-9.

  PMID: 11024415 BACKGROUND

• AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS): 9. Comparison of glaucoma outcomes in black and white patients within treatment groups. Am J Ophthalmol. 2001 Sep;132(3):311-20. doi: 10.1016/s0002-9394(01)01028-5.

  PMID: 11530042 BACKGROUND

• Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol. 1998 Oct;126(4):487-97. doi: 10.1016/s0002-9394(98)00223-2.

  PMID: 9780093 BACKGROUND

• Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.

  PMID: 12049574 BACKGROUND

• Konstas AG, Maskaleris G, Gratsonidis S, Sardelli C. Compliance and viewpoint of glaucoma patients in Greece. Eye (Lond). 2000 Oct;14 Pt 5:752-6. doi: 10.1038/eye.2000.197.

  PMID: 11116698 BACKGROUND

• Brown MM, Brown GC, Spaeth GL. Improper topical self-administration of ocular medication among patients with glaucoma. Can J Ophthalmol. 1984 Feb;19(1):2-5.

  PMID: 6608974 BACKGROUND

• Gedde SJ, Feuer WJ, Shi W, Lim KS, Barton K, Goyal S, Ahmed IIK, Brandt J; Primary Tube Versus Trabeculectomy Study Group. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up. Ophthalmology. 2018 May;125(5):650-663. doi: 10.1016/j.ophtha.2018.02.003. Epub 2018 Feb 21.

  PMID: 29477688 BACKGROUND

• Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC. Surgical complications in the Tube Versus Trabeculectomy Study during the first year of follow-up. Am J Ophthalmol. 2007 Jan;143(1):23-31. doi: 10.1016/j.ajo.2006.07.022. Epub 2006 Sep 1.

  PMID: 17054896 BACKGROUND

• Katz LJ. A call for innovative operations for glaucoma. Arch Ophthalmol. 2000 Mar;118(3):412-3. doi: 10.1001/archopht.118.3.412. No abstract available.

  PMID: 10721967 BACKGROUND

• Shields MB. Cyclodestructive surgery for glaucoma: past, present, and future. Trans Am Ophthalmol Soc. 1985;83:285-303.

  PMID: 3832531 BACKGROUND

• Bloom PA, Dharmaraj S. Endoscopic and transscleral cyclophotocoagulation. Br J Ophthalmol. 2006 Jun;90(6):666-8. doi: 10.1136/bjo.2005.082073.

  PMID: 16714260 BACKGROUND

• Pastor SA, Singh K, Lee DA, Juzych MS, Lin SC, Netland PA, Nguyen NT. Cyclophotocoagulation: a report by the American Academy of Ophthalmology. Ophthalmology. 2001 Nov;108(11):2130-8. doi: 10.1016/s0161-6420(01)00889-2.

  PMID: 11713091 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Cataract; Glaucoma

Interventions

Lasers

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Lina Danieliute, MSc, PGCert

CONTACT

02071884885; lina.danieliute@gstt.nhs.uk

Sheng Lim, MD, FRCOphth

CONTACT

sheng.lim@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 4, 2020
• Study Start: March 15, 2020
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2023
• Last Updated: March 4, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share