The American Glaucoma Society (AGS) Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study (ASSISTS)

NCT02691455 | Terminated Results DMC

• 1 other identifier: HSC-MS-15-1053
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 23

Brief Summary

Outcomes of subjects with uncontrolled glaucoma with a single existing aqueous tube shunt implant undergoing a second aqueous shunt to transscleral diode laser cyclophotocoagulation.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (3)

• Number of Eyes That Failed Treatment

  Treatment failure is defined as meeting one or more of the following 4 criteria: 1. Intraocular pressure (IOP) a) \>18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of \< 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or 2. Reoperation for glaucoma; or 3. Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or 4. Loss of light perception vision (NLP).

  from time of intervention to month 6

• Number of Eyes That Failed Treatment

  Treatment failure is defined as meeting one or more of the following 4 criteria: 1. Intraocular pressure (IOP) a) \>18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of \< 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or 2. Reoperation for glaucoma; or 3. Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or 4. Loss of light perception vision (NLP).

  from month 6 to month 12

• Number of Eyes That Failed Treatment

  Treatment failure is defined as meeting one or more of the following 4 criteria: 1. Intraocular pressure (IOP) a) \>18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of \< 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or 2. Reoperation for glaucoma; or 3. Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or 4. Loss of light perception vision (NLP).

  from month 12 to year 3

Secondary Outcomes (39)

• Number of Eyes With Vision-threatening Complications

  from the time of intervention to year 3

• Number of Eyes That Lost Two or More Lines of Vision as Assessed by the Snellen Chart Visual Acuity Test

  from time of intervention to year 3

• Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

  baseline, week 1

• Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

  baseline, month 1

• Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

  baseline, month 3

Study Arms (2)

Second Aqueous Shunt

ACTIVE COMPARATOR

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.

Device: Baerveldt Glaucoma Implant 350-mm2 / BG101-350; Device: Ahmed Model FP7 Flexible Plate; Device: Baerveldt Glaucoma Implant 250-mm2 / BG103-250

Transscleral Cyclophotocoagulation

ACTIVE COMPARATOR

Transscleral Diode Laser Cyclophotocoagulation

Procedure: Transscleral Diode Laser Cyclophotocoagulation

Interventions

Baerveldt Glaucoma Implant 350-mm2 / BG101-350 DEVICE

Second Aqueous Shunt

Transscleral Diode Laser Cyclophotocoagulation PROCEDURE

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.

Also known as: Transscleral Diode Laser Cyclophotocoagulation (TLC)

Transscleral Cyclophotocoagulation

Ahmed Model FP7 Flexible Plate DEVICE

Second Aqueous Shunt

Baerveldt Glaucoma Implant 250-mm2 / BG103-250 DEVICE

Second Aqueous Shunt

Eligibility Criteria

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

You may qualify if:

• Women and men 18 to 85 years of age
• 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

You may not qualify if:

• Monocular
• 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

Sponsors & Collaborators

• Robert Feldman: lead

Study Sites (23)

University of California San Diego - Shiley Eye Institute

La Jolla, California, 92093, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Bascom Palmer Eye Institute - Miami

Miami, Florida, 33136, United States

Location

Bascom Palmer Eye Institute

Palm Beach Gardens, Florida, 33418, United States

Location

Northwestern University - Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Stiles Eyecare Excellence and Glaucoma Institute

Overland Park, Kansas, 66213, United States

Location

New England Eye Center - Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Glaucoma Consultants of St. Louis

Chesterfield, Missouri, 63017, United States

Location

Rutgers; New Jersey Medical School; IOVS

Newark, New Jersey, 07103, United States

Location

Glaucoma Institute of Northern NJ, LLC

Rochelle Park, New Jersey, 07062, United States

Location

New York Eye and Ear Infirmary of Mount Sinai

New York, New York, 10003, United States

Location

Edward Harkness Eye Institute / Columbia University Medical Center

New York, New York, 10032, United States

Location

UNC Kittner Eye Center

Chapel Hill, North Carolina, 27517, United States

Location

Devers Eye Institute/Legacy Health

Portland, Oregon, 97210, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt Eye Institute

Nashville, Tennessee, 37232, United States

Location

Robert Cizik Eye Clinic

Houston, Texas, 77030, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

Virginia Eye Institute

Richmond, Virginia, 23226, United States

Location

University of Washington Medicine Eye Institute

Seattle, Washington, 98104, United States

Location

WVU Eye Institute

Morgantown, West Virginia, 26506, United States

Location

Related Publications (17)

• 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.

  PMID: 26092196 BACKGROUND

• 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.

  PMID: 22245458 BACKGROUND

• 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.

  PMID: 25439606 BACKGROUND

• 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.

  PMID: 19837382 BACKGROUND

• 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.

  PMID: 10690831 BACKGROUND

• 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.

  PMID: 21336148 BACKGROUND

• 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.

  PMID: 26334729 BACKGROUND

• 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.

  PMID: 12045047 BACKGROUND

• 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.

  PMID: 19365202 BACKGROUND

• 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.

  PMID: 11820661 BACKGROUND

• 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.

  PMID: 26091182 BACKGROUND

• 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.

  PMID: 21048513 BACKGROUND

• 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.

  PMID: 19683190 BACKGROUND

• 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.

  PMID: 26024673 BACKGROUND

• 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.

  PMID: 15919228 BACKGROUND

• 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.

  PMID: 36848258 DERIVED

• 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.

  PMID: 35901309 DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Robert M. Feldman, MD
• Organization: The University of Texas Health Science Center at Houston

Robert.M.Feldman@uth.tmc.edu

(713) 559-5239

Study Officials

• Robert Feldman, MD

  Robert Cizik Eye Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: February 25, 2016
• Study Start: February 1, 2016
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: November 2, 2021
• Results First Posted: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

US (23)