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

Glaucoma Clinical Trial

— ASSISTS  

Official title:

The AGS Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02691455
• Other study ID #: HSC-MS-15-1053
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a study comparing short- (1 year), mid- (3 years), and long-term (5 years) cumulative incidences of failures in participants who undergo a second aqueous shunt (SAS) to those cumulative incidences of failures in participants who undergo a second aqueous shunt (SAS) to those cumulative incidences of failures in participants who undergo transscleral diode laser cyclophotocoagulation (TLC) for eyes with uncontrolled glaucoma with a single existing aqueous tube shunt procedure.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Unwilling or unable to give consent and satisfy requirements of the study

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Baerveldt Glaucoma Implant 350-mm2 / BG101-350

Procedure:
• 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.

Device:
• Ahmed Model FP7 Flexible Plate

• Baerveldt Glaucoma Implant 250-mm2 / BG103-250

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
United States	New England Eye Center - Tufts Medical Center	Boston	Massachusetts
United States	UNC Kittner Eye Center	Chapel Hill	North Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Glaucoma Consultants of St. Louis	Chesterfield	Missouri
United States	Northwestern University - Feinberg School of Medicine	Chicago	Illinois
United States	Robert Cizik Eye Clinic	Houston	Texas
United States	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	WVU Eye Institute	Morgantown	West Virginia
United States	Vanderbilt Eye Institute	Nashville	Tennessee
United States	Edward Harkness Eye Institute / Columbia University Medical Center	New York	New York
United States	New York Eye and Ear Infirmary of Mount Sinai	New York	New York
United States	Rutgers; New Jersey Medical School; IOVS	Newark	New Jersey
United States	Stiles Eyecare Excellence and Glaucoma Institute	Overland Park	Kansas
United States	Bascom Palmer Eye Institute	Palm Beach Gardens	Florida
United States	Wills Eye Hospital	Philadelphia	Pennsylvania
United States	UPMC Eye Center	Pittsburgh	Pennsylvania
United States	Devers Eye Institute/Legacy Health	Portland	Oregon
United States	Virginia Eye Institute	Richmond	Virginia
United States	Glaucoma Institute of Northern NJ, LLC	Rochelle Park	New Jersey
United States	University of Washington Medicine Eye Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Robert Feldman

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

Burgoyne JK, WuDunn D, Lakhani V, Cantor LB. Outcomes of sequential tube shunts in complicated glaucoma. Ophthalmology. 2000 Feb;107(2):309-14. — View Citation

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. — View Citation

Gabelt BT, Kaufman PL. Changes in aqueous humor dynamics with age and glaucoma. Prog Retin Eye Res. 2005 Sep;24(5):612-37. Review. — View Citation

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. — View Citation

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. — View Citation

Jiménez-Román J, Gil-Carrasco F, Costa VP, Schimiti RB, Lerner F, Santana PR, Vascocellos JP, Castillejos-Chévez 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Eyes That Failed Treatment	Treatment failure is defined as meeting one or more of the following 4 criteria: 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; Reoperation for glaucoma; or; Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or; Loss of light perception vision (NLP).	from time of intervention to month 6
Primary	Number of Eyes That Failed Treatment	Treatment failure is defined as meeting one or more of the following 4 criteria: 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; Reoperation for glaucoma; or; Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or; Loss of light perception vision (NLP).	from month 6 to month 12
Primary	Number of Eyes That Failed Treatment	Treatment failure is defined as meeting one or more of the following 4 criteria: 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; Reoperation for glaucoma; or; Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or; Loss of light perception vision (NLP).	from month 12 to year 3
Secondary	Number of Eyes With Vision-threatening Complications		from the time of intervention to year 3
Secondary	Number of Eyes That Lost Two or More Lines of Vision as Assessed by the Snellen Chart Visual Acuity Test	The Snellen visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). Loss of lines of vision indicates worsening visual acuity.	from time of intervention to year 3
Secondary	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The week 1 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).	baseline, week 1
Secondary	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 1 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).	baseline, month 1
Secondary	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 3 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).	baseline, month 3
Secondary	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 6 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).	baseline, month 6
Secondary	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 12 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).	baseline, month 12
Secondary	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The year 2 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).	baseline, year 2
Secondary	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The year 3 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).	baseline, year 3
Secondary	Incidence of Pain	Number of participants who reported pain.	1 week
Secondary	Incidence of Pain	Number of participants who reported pain.	1 month
Secondary	Severity of Pain	Severity of pain was assessed by the Universal Pain Assessment Tool, and the score ranges from 0 to 10, with a higher score indicating greater pain.	1 week
Secondary	Severity of Pain	Severity of pain was assessed by the Universal Pain Assessment Tool, and the score ranges from 0 to 10, with a higher score indicating greater pain.	1 month
Secondary	Number of Office Visits Per Participant From Baseline to 3 Months		from baseline to 3 months
Secondary	Number of Office Visits Per Participant Per Month After Month 3		from month 4 to year 3
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 (NEI-VFQ-25) - General Health Subscale	The score on the National Eye Institute (NEI) Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	baseline
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Health Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	month 12
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Vision Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	baseline
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Vision Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	month 12
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Mental Health Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	baseline
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Mental Health Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	month 12
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Distance Activity Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	baseline
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Distance Activity Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	month 12
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Near Activity Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	baseline
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Near Activity Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	month 12
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Peripheral Vision Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	baseline
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Peripheral Vision Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	month 12
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Color Vision Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	baseline
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Color Vision Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	month 12
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Ocular Pain Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	baseline
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Ocular Pain Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	month 12
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	baseline
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	month 12
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	baseline
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	month 12
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Social Functioning Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	baseline
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Social Functioning Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	month 12
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Role Difficulty Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	baseline
Secondary	Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Role Difficulty Subscale	The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.	month 12