The American Glaucoma Society (AGS) Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study (ASSISTS)
NCT ID: NCT02691455
Last Updated: 2021-11-02
Study Results
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View full resultsBasic Information
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TERMINATED
NA
50 participants
INTERVENTIONAL
2016-02-29
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Second Aqueous Shunt
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
Transscleral Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation
Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
Interventions
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Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Transscleral Diode Laser Cyclophotocoagulation
Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Glaucoma not adequately controlled (IOP \>18 mmHg on maximum tolerated topical therapy) with a single aqueous shunt (AS).
* Best-corrected visual acuity (BCVA) of hand motion (HM) or better in the study eye
Exclusion Criteria
* Presence of more than one AS in the study eye
* Previous cyclodestruction in the study eye
* Presence of active iris neovascularization in the study eye
* Binocular diplopia
* Presence of scleral buckle in the study eye
* History or scleritis in either eye
* History of scleromalacia in the study eye
* Insufficient conjunctiva to cover AS in the study eye
* IOP cannot be accurately measured with Goldmann applanation, Pneumotonometry, or Tono-Pen in the study eye
* Presence of silicone oil in the study eye
* Presence of retinal detachment in the study eye
* Presence of intraocular or orbital tumor affecting the study eye
* Need for cataract extraction or concurrent procedure at the time of study treatment, except tectonic aqueous shunt revisions for both groups is allowed.
* In the opinion of the investigator, should not be enrolled in this study
* Unwilling or unable to give consent and satisfy requirements of the study
18 Years
85 Years
ALL
No
Sponsors
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Robert Feldman
OTHER
Responsible Party
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Robert Feldman
M.D.
Principal Investigators
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Robert Feldman, MD
Role: STUDY_CHAIR
Robert Cizik Eye Clinic
Locations
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University of California San Diego - Shiley Eye Institute
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
Bascom Palmer Eye Institute - Miami
Miami, Florida, United States
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, United States
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, United States
Stiles Eyecare Excellence and Glaucoma Institute
Overland Park, Kansas, United States
New England Eye Center - Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Glaucoma Consultants of St. Louis
Chesterfield, Missouri, United States
Rutgers; New Jersey Medical School; IOVS
Newark, New Jersey, United States
Glaucoma Institute of Northern NJ, LLC
Rochelle Park, New Jersey, United States
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, United States
Edward Harkness Eye Institute / Columbia University Medical Center
New York, New York, United States
UNC Kittner Eye Center
Chapel Hill, North Carolina, United States
Devers Eye Institute/Legacy Health
Portland, Oregon, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
UPMC Eye Center
Pittsburgh, Pennsylvania, United States
Vanderbilt Eye Institute
Nashville, Tennessee, United States
Robert Cizik Eye Clinic
Houston, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Virginia Eye Institute
Richmond, Virginia, United States
University of Washington Medicine Eye Institute
Seattle, Washington, United States
WVU Eye Institute
Morgantown, West Virginia, United States
Countries
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References
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Arora KS, Robin AL, Corcoran KJ, Corcoran SL, Ramulu PY. Use of Various Glaucoma Surgeries and Procedures in Medicare Beneficiaries from 1994 to 2012. Ophthalmology. 2015 Aug;122(8):1615-24. doi: 10.1016/j.ophtha.2015.04.015. Epub 2015 Jun 16.
Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL; Tube versus Trabeculectomy Study Group. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012 May;153(5):789-803.e2. doi: 10.1016/j.ajo.2011.10.026. Epub 2012 Jan 15.
Budenz DL, Barton K, Gedde SJ, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, Buys YM; Ahmed Baerveldt Comparison Study Group. Five-year treatment outcomes in the Ahmed Baerveldt comparison study. Ophthalmology. 2015 Feb;122(2):308-16. doi: 10.1016/j.ophtha.2014.08.043. Epub 2014 Oct 17.
Anand A, Tello C, Sidoti PA, Ritch R, Liebmann JM. Sequential glaucoma implants in refractory glaucoma. Am J Ophthalmol. 2010 Jan;149(1):95-101. doi: 10.1016/j.ajo.2009.07.019. Epub 2009 Oct 17.
Burgoyne JK, WuDunn D, Lakhani V, Cantor LB. Outcomes of sequential tube shunts in complicated glaucoma. Ophthalmology. 2000 Feb;107(2):309-14. doi: 10.1016/s0161-6420(99)00039-1.
Ness PJ, Khaimi MA, Feldman RM, Tabet R, Sarkisian SR Jr, Skuta GL, Chuang AZ, Mankiewicz KA. Intermediate term safety and efficacy of transscleral cyclophotocoagulation after tube shunt failure. J Glaucoma. 2012 Feb;21(2):83-8. doi: 10.1097/IJG.0b013e31820bd1ce.
Jimenez-Roman J, Gil-Carrasco F, Costa VP, Schimiti RB, Lerner F, Santana PR, Vascocellos JP, Castillejos-Chevez A, Turati M, Fabre-Miranda K. Intraocular pressure control after the implantation of a second Ahmed glaucoma valve. Int Ophthalmol. 2016 Jun;36(3):347-53. doi: 10.1007/s10792-015-0125-z. Epub 2015 Sep 3.
Semchyshyn TM, Tsai JC, Joos KM. Supplemental transscleral diode laser cyclophotocoagulation after aqueous shunt placement in refractory glaucoma. Ophthalmology. 2002 Jun;109(6):1078-84. doi: 10.1016/s0161-6420(02)01019-9.
Smith M, Buys YM, Trope GE. Second Ahmed valve insertion in the same eye. J Glaucoma. 2009 Apr-May;18(4):336-40. doi: 10.1097/IJG.0b013e318182edfb.
Godfrey DG, Krishna R, Greenfield DS, Budenz DL, Gedde SJ, Scott IU. Implantation of second glaucoma drainage devices after failure of primary devices. Ophthalmic Surg Lasers. 2002 Jan-Feb;33(1):37-43.
Ko SJ, Hwang YH, Ahn SI, Kim HK. Surgical Outcomes of Additional Ahmed Glaucoma Valve Implantation in Refractory Glaucoma. J Glaucoma. 2016 Jun;25(6):e620-4. doi: 10.1097/IJG.0000000000000298.
Francis BA, Kawji AS, Vo NT, Dustin L, Chopra V. Endoscopic cyclophotocoagulation (ECP) in the management of uncontrolled glaucoma with prior aqueous tube shunt. J Glaucoma. 2011 Oct;20(8):523-7. doi: 10.1097/IJG.0b013e3181f46337.
Sood S, Beck AD. Cyclophotocoagulation versus sequential tube shunt as a secondary intervention following primary tube shunt failure in pediatric glaucoma. J AAPOS. 2009 Aug;13(4):379-83. doi: 10.1016/j.jaapos.2009.05.006.
Schaefer JL, Levine MA, Martorana G, Koenigsman H, Smith MF, Sherwood MB. Failed glaucoma drainage implant: long-term outcomes of a second glaucoma drainage device versus cyclophotocoagulation. Br J Ophthalmol. 2015 Dec;99(12):1718-24. doi: 10.1136/bjophthalmol-2015-306725. Epub 2015 May 29.
Gabelt BT, Kaufman PL. Changes in aqueous humor dynamics with age and glaucoma. Prog Retin Eye Res. 2005 Sep;24(5):612-37. doi: 10.1016/j.preteyeres.2004.10.003.
Ma JX, Chuang AZ, Feldman RM, Mansberger SL, Tanna AP, Blieden LS, Shoham D, Bell NP, Gross RL, Pasquale LR, Greenfield DS, Liebmann JM, Weinreb RN; ASSISTS Study Group. Direct Costs of Second Aqueous Shunt Implant Versus Transscleral Cyclophotocoagulation (The Assists Trial). J Glaucoma. 2023 Mar 1;32(3):145-150. doi: 10.1097/IJG.0000000000002143. Epub 2023 Feb 1.
Feldman RM, Chuang AZ, Mansberger SL, Tanna AP, Blieden LS, Bell NP, Gross RL, Pasquale LR, Greenfield DS, Liebmann JM, Weinreb RN; ASSISTS Group. Outcomes of the Second Aqueous Shunt Implant Versus Transscleral Cyclophotocoagulation Treatment Study: A Randomized Comparative Trial. J Glaucoma. 2022 Sep 1;31(9):701-709. doi: 10.1097/IJG.0000000000002079. Epub 2022 Jul 21.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-MS-15-1053
Identifier Type: -
Identifier Source: org_study_id