Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma
NCT ID: NCT03187418
Last Updated: 2021-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2017-06-19
2020-02-15
Brief Summary
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Detailed Description
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Traditional trans-scleral cyclophotocoagulation (TSCPC) achieve its cyclodestructive action by using continuous diode laser to target the melanin in the pigmented ciliary body epithelium. However, the continuous mode has been shown to cause significant collateral tissue damage to adjacent non-pigmented structures including the ciliary stroma and ciliary muscle. Traditional TSCPC may therefore be associated with serious complications including uveitis, visual deterioration, chronic hypotony, and others.
More recently, a micropulse delivery mode of diode laser (Micropulse TSCPC, mTSCPC) has been used to treat glaucoma by ablating the ciliary processes and reduce aqueous humor production with more selective targeting and less collateral damage. In contrast to conventional laser delivery where a continuous flow of high intensity energy is delivered, micropulse laser application delivers a series of repetitive short pulses of energy with rest periods in between pulses. Only a few studies have described the outcomes of this novel glaucoma therapy, showing mTSCPC to have comparable efficacy with fewer side effects when compared with traditional continuous wave mode diode laser delivery.This improved side effect profile has the potential to make mTSCPC an earlier therapeutic option instead of reserving it exclusively for end-stage refractory eyes.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Micropulse trans-scleral CPC
A treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA).
MicroPulse® P3 Glaucoma Device (MP3)
Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %.
The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus).
The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
Interventions
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MicroPulse® P3 Glaucoma Device (MP3)
Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %.
The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus).
The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Followed by a glaucoma subspecialist at University of Montreal Hospital Center.
* Intraocular pressure (IOP) above target and unresponsive to maximal tolerated medical therapy with or without previous surgical intervention.
1. mild glaucoma: IOP \> 18 mmHg
2. moderate glaucoma: IOP \> 15 mmHg
3. advanced glaucoma: IOP \> 12 mmHg
* Considered poor candidates for additional filtering surgery or implantation of glaucoma drainage devices.
Exclusion Criteria
* Patients with significant scleral thinning, defined as thinning of more than one clock hour noticed on scleral transillumination.
* Ocular infection or inflammation in the study eye in the 2 months prior to enrolment.
* Intraocular surgery in the study eye in the 2 months prior to enrolment.
18 Years
ALL
Yes
Sponsors
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Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Responsible Party
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Principal Investigators
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Harmanjit Singh, MD
Role: PRINCIPAL_INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Michael Marchand, MD
Role: PRINCIPAL_INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Locations
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Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
Countries
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References
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Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.
Nguyen QH. Primary surgical management refractory glaucoma: tubes as initial surgery. Curr Opin Ophthalmol. 2009 Mar;20(2):122-5. doi: 10.1097/ICU.0b013e32831da828.
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Agarwal HC, Gupta V, Sihota R. Evaluation of contact versus non-contact diode laser cyclophotocoagulation for refractory glaucomas using similar energy settings. Clin Exp Ophthalmol. 2004 Feb;32(1):33-8. doi: 10.1046/j.1442-9071.2004.00754.x.
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Egbert PR, Fiadoyor S, Budenz DL, Dadzie P, Byrd S. Diode laser transscleral cyclophotocoagulation as a primary surgical treatment for primary open-angle glaucoma. Arch Ophthalmol. 2001 Mar;119(3):345-50. doi: 10.1001/archopht.119.3.345.
Leszczynski R, Gierek-Lapinska A, Forminska - Kapuscik M. Transscleral cyclophotocoagulation in the treatment of secondary glaucoma. Med Sci Monit. 2004 Sep;10(9):CR542-8. Epub 2004 Aug 20.
Rotchford AP, Jayasawal R, Madhusudhan S, Ho S, King AJ, Vernon SA. Transscleral diode laser cycloablation in patients with good vision. Br J Ophthalmol. 2010 Sep;94(9):1180-3. doi: 10.1136/bjo.2008.145565. Epub 2010 Jun 24.
Pantcheva MB, Kahook MY, Schuman JS, Rubin MW, Noecker RJ. Comparison of acute structural and histopathological changes of the porcine ciliary processes after endoscopic cyclophotocoagulation and transscleral cyclophotocoagulation. Clin Exp Ophthalmol. 2007 Apr;35(3):270-4. doi: 10.1111/j.1442-9071.2006.01415.x.
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Aquino MC, Barton K, Tan AM, Sng C, Li X, Loon SC, Chew PT. Micropulse versus continuous wave transscleral diode cyclophotocoagulation in refractory glaucoma: a randomized exploratory study. Clin Exp Ophthalmol. 2015 Jan-Feb;43(1):40-6. doi: 10.1111/ceo.12360. Epub 2014 Jun 21.
Bloom PA, Tsai JC, Sharma K, Miller MH, Rice NS, Hitchings RA, Khaw PT. "Cyclodiode". Trans-scleral diode laser cyclophotocoagulation in the treatment of advanced refractory glaucoma. Ophthalmology. 1997 Sep;104(9):1508-19; discussion 1519-20. doi: 10.1016/s0161-6420(97)30109-2.
Kosoko O, Gaasterland DE, Pollack IP, Enger CL. Long-term outcome of initial ciliary ablation with contact diode laser transscleral cyclophotocoagulation for severe glaucoma. The Diode Laser Ciliary Ablation Study Group. Ophthalmology. 1996 Aug;103(8):1294-302. doi: 10.1016/s0161-6420(96)30508-3.
Mistlberger A, Liebmann JM, Tschiderer H, Ritch R, Ruckhofer J, Grabner G. Diode laser transscleral cyclophotocoagulation for refractory glaucoma. J Glaucoma. 2001 Aug;10(4):288-93. doi: 10.1097/00061198-200108000-00008.
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Sivaprasad S, Sandhu R, Tandon A, Sayed-Ahmed K, McHugh DA. Subthreshold micropulse diode laser photocoagulation for clinically significant diabetic macular oedema: a three-year follow up. Clin Exp Ophthalmol. 2007 Sep-Oct;35(7):640-4. doi: 10.1111/j.1442-9071.2007.01566.x.
Parodi MB, Spasse S, Iacono P, Di Stefano G, Canziani T, Ravalico G. Subthreshold grid laser treatment of macular edema secondary to branch retinal vein occlusion with micropulse infrared (810 nanometer) diode laser. Ophthalmology. 2006 Dec;113(12):2237-42. doi: 10.1016/j.ophtha.2006.05.056. Epub 2006 Sep 25.
Desmettre TJ, Mordon SR, Buzawa DM, Mainster MA. Micropulse and continuous wave diode retinal photocoagulation: visible and subvisible lesion parameters. Br J Ophthalmol. 2006 Jun;90(6):709-12. doi: 10.1136/bjo.2005.086942. Epub 2006 Mar 10.
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Pollack JS, Kim JE, Pulido JS, Burke JM. Tissue effects of subclinical diode laser treatment of the retina. Arch Ophthalmol. 1998 Dec;116(12):1633-9. doi: 10.1001/archopht.116.12.1633.
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Kuchar S, Moster MR, Reamer CB, Waisbourd M. Treatment outcomes of micropulse transscleral cyclophotocoagulation in advanced glaucoma. Lasers Med Sci. 2016 Feb;31(2):393-6. doi: 10.1007/s10103-015-1856-9. Epub 2015 Dec 29.
Hauber FA, Scherer WJ. Influence of total energy delivery on success rate after contact diode laser transscleral cyclophotocoagulation: a retrospective case review and meta-analysis. J Glaucoma. 2002 Aug;11(4):329-33. doi: 10.1097/00061198-200208000-00009.
Vernon SA, Koppens JM, Menon GJ, Negi AK. Diode laser cycloablation in adult glaucoma: long-term results of a standard protocol and review of current literature. Clin Exp Ophthalmol. 2006 Jul;34(5):411-20. doi: 10.1111/j.1442-9071.2006.01241.x.
Murphy CC, Burnett CA, Spry PG, Broadway DC, Diamond JP. A two centre study of the dose-response relation for transscleral diode laser cyclophotocoagulation in refractory glaucoma. Br J Ophthalmol. 2003 Oct;87(10):1252-7. doi: 10.1136/bjo.87.10.1252.
Meyer JJ, Lawrence SD. What's new in laser treatment for glaucoma? Curr Opin Ophthalmol. 2012 Mar;23(2):111-7. doi: 10.1097/ICU.0b013e32834f1887.
Marchand M, Singh H, Agoumi Y. Micropulse trans-scleral laser therapy outcomes for uncontrolled glaucoma: a prospective 18-month study. Can J Ophthalmol. 2021 Dec;56(6):371-378. doi: 10.1016/j.jcjo.2021.01.015. Epub 2021 Feb 10.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CE16.351
Identifier Type: -
Identifier Source: org_study_id
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