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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02691455

Acronym

ASSISTS

Enrollment

Registered

2016-02-25

Start date

2016-02-29

Completion date

2020-09-30

Last updated

2021-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

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.

Detailed 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.

Interventions

DEVICEBaerveldt Glaucoma Implant 350-mm2 / BG101-350

PROCEDURETransscleral 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.

DEVICEAhmed Model FP7 Flexible Plate

DEVICEBaerveldt Glaucoma Implant 250-mm2 / BG103-250

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Eyes That Failed Treatment	from time of intervention to month 6	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).

Secondary

Countries

United States

Participant flow

Pre-assignment details

5 enrolled participants did not meet eligibility criteria and were excluded. Only one eye of each participant was eligible for enrollment.

Participants by arm

Arm	Count
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	22
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.	20
Total	42

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	15	15
Overall Study	Withdrawal by Subject	1	2

Baseline characteristics

Characteristic	Second Aqueous Shunt	Transscleral Cyclophotocoagulation	Total
Age, Continuous	63.1 years STANDARD_DEVIATION 11.2	64.2 years STANDARD_DEVIATION 9.8	63.6 years STANDARD_DEVIATION 10.4
Best corrected visual acuity as Assessed by the Snellen Chart Visual Acuity Test	0.97 logMAR STANDARD_DEVIATION 0.9	0.49 logMAR STANDARD_DEVIATION 0.66	0.74 logMAR STANDARD_DEVIATION 0.82
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants	7 Participants	13 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants	13 Participants	29 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Glaucoma type Mixed Open and Closed Glaucoma	2 Participants	1 Participants	3 Participants
Glaucoma type Neovascular	3 Participants	3 Participants	6 Participants
Glaucoma type Other Secondary Glaucoma	5 Participants	2 Participants	7 Participants
Glaucoma type Primary Angle Closure	1 Participants	1 Participants	2 Participants
Glaucoma type Primary Open Angle	9 Participants	10 Participants	19 Participants
Glaucoma type Uveitis	2 Participants	3 Participants	5 Participants
Intraocular pressure (IOP)	27.6 mmHg STANDARD_DEVIATION 8.7	26.2 mmHg STANDARD_DEVIATION 9.7	26.9 mmHg STANDARD_DEVIATION 9.1
Number of ocular hypertensive medications per participant	3.2 medications STANDARD_DEVIATION 0.8	3.3 medications STANDARD_DEVIATION 1.1	3.2 medications STANDARD_DEVIATION 0.9
Number of participants for whom study eye is right eye	15 Participants	5 Participants	20 Participants
Number of participants on ocular hypertensive medications	21 Participants	20 Participants	41 Participants
Number of participants on oral carbonic anhydrase inhibitor (CAI)	2 Participants	4 Participants	6 Participants
Number of participants with autoimmune disease	3 Participants	1 Participants	4 Participants
Number of participants with diabetes	9 Participants	8 Participants	17 Participants
Number of participants with hypertension	17 Participants	15 Participants	32 Participants
Race/Ethnicity, Customized Black	9 Participants	8 Participants	17 Participants
Race/Ethnicity, Customized Other	2 Participants	3 Participants	5 Participants
Race/Ethnicity, Customized White	11 Participants	9 Participants	20 Participants
Region of Enrollment United States	22 Participants	20 Participants	42 Participants
Sex: Female, Male Female	9 Participants	9 Participants	18 Participants
Sex: Female, Male Male	13 Participants	11 Participants	24 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	3 / 22	0 / 20
other Total, other adverse events	10 / 22	10 / 20
serious Total, serious adverse events	6 / 22	3 / 20

Outcome results

Primary

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).

Time frame: from time of intervention to month 6

Population: Only one eye of each participant was eligible for enrollment. Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (NUMBER)
Second Aqueous Shunt	Number of Eyes That Failed Treatment	0 eyes
Transscleral Cyclophotocoagulation	Number of Eyes That Failed Treatment	0 eyes

Primary

Number of Eyes That Failed Treatment

Time frame: from month 6 to month 12

Population: Only one eye of each participant was eligible for enrollment. Data for this outcome measure were not collected for 4 in the Second Aqueous Shunt arm and 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (NUMBER)
Second Aqueous Shunt	Number of Eyes That Failed Treatment	3 eyes
Transscleral Cyclophotocoagulation	Number of Eyes That Failed Treatment	2 eyes

Primary

Number of Eyes That Failed Treatment

Time frame: from month 12 to year 3

Population: Only one eye of each participant was eligible for enrollment. Only those who did not fail treatment in the previous time period (previous time period is reported in Outcome measure 2) were analyzed in this time period. Data for this outcome measure were not collected for 15 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (NUMBER)
Second Aqueous Shunt	Number of Eyes That Failed Treatment	0 eyes
Transscleral Cyclophotocoagulation	Number of Eyes That Failed Treatment	0 eyes

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).

Time frame: baseline, year 3

Population: Data for this outcome measure were not collected for 16 in the Second Aqueous Shunt arm and 15 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Second Aqueous Shunt	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	-0.23 log MAgnification Requirement (logMAR)	Standard Deviation 0.36
Transscleral Cyclophotocoagulation	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	0.49 log MAgnification Requirement (logMAR)	Standard Deviation 0.76

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).

Time frame: baseline, week 1

Population: Data for this outcome measure was not collected 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Second Aqueous Shunt	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	0.16 log MAgnification Requirement (logMAR)	Standard Deviation 0.45
Transscleral Cyclophotocoagulation	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	0.14 log MAgnification Requirement (logMAR)	Standard Deviation 0.37

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).

Time frame: baseline, month 1

Population: Data for this outcome measure was not collected for 5 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Second Aqueous Shunt	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	-0.03 log MAgnification Requirement (logMAR)	Standard Deviation 0.18
Transscleral Cyclophotocoagulation	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	0.12 log MAgnification Requirement (logMAR)	Standard Deviation 0.2

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 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).

Time frame: baseline, month 3

Population: Data for this outcome measure were not collected for 1 in the Second Aqueous Shunt arm and 3 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Second Aqueous Shunt	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	-0.10 log MAgnification Requirement (logMAR)	Standard Deviation 0.27
Transscleral Cyclophotocoagulation	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	0.08 log MAgnification Requirement (logMAR)	Standard Deviation 0.13

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).

Time frame: baseline, month 6

Population: Data for this outcome measure were not collected for 3 in the Second Aqueous Shunt arm and 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Second Aqueous Shunt	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	-0.03 log MAgnification Requirement (logMAR)	Standard Deviation 0.28
Transscleral Cyclophotocoagulation	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	0.05 log MAgnification Requirement (logMAR)	Standard Deviation 0.3

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 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).

Time frame: baseline, month 12

Population: Data for this outcome measure were not collected for 6 in the Second Aqueous Shunt arm and 4 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Second Aqueous Shunt	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	-0.06 log MAgnification Requirement (logMAR)	Standard Deviation 0.34
Transscleral Cyclophotocoagulation	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	0.09 log MAgnification Requirement (logMAR)	Standard Deviation 0.31

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).

Time frame: baseline, year 2

Population: Data for this outcome measure were not collected for 16 in the Second Aqueous Shunt arm and 11 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Second Aqueous Shunt	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	-0.28 log MAgnification Requirement (logMAR)	Standard Deviation 0.28
Transscleral Cyclophotocoagulation	Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test	0.24 log MAgnification Requirement (logMAR)	Standard Deviation 0.46

Secondary

Incidence of Pain

Number of participants who reported pain.

Time frame: 1 month

Population: Data for this outcome measure were not collected for 2 in the Second Aqueous Shunt arm and 2 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Second Aqueous Shunt	Incidence of Pain	10 Participants
Transscleral Cyclophotocoagulation	Incidence of Pain	10 Participants

Secondary

Incidence of Pain

Number of participants who reported pain.

Time frame: 1 week

Population: Data for this outcome measure were not collected for 1 in the Second Aqueous Shunt arm and 2 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Second Aqueous Shunt	Incidence of Pain	12 Participants
Transscleral Cyclophotocoagulation	Incidence of Pain	11 Participants

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.

Time frame: from time of intervention to year 3

Arm	Measure	Value (NUMBER)
Second Aqueous Shunt	Number of Eyes That Lost Two or More Lines of Vision as Assessed by the Snellen Chart Visual Acuity Test	3 eyes
Transscleral Cyclophotocoagulation	Number of Eyes That Lost Two or More Lines of Vision as Assessed by the Snellen Chart Visual Acuity Test	8 eyes

Secondary

Number of Eyes With Vision-threatening Complications

Time frame: from the time of intervention to year 3

Arm	Measure	Group	Value (NUMBER)
Second Aqueous Shunt	Number of Eyes With Vision-threatening Complications	Macular Hole	0 eyes
Second Aqueous Shunt	Number of Eyes With Vision-threatening Complications	Choroidal Effusion	1 eyes
Second Aqueous Shunt	Number of Eyes With Vision-threatening Complications	Herpes Simplex Keratitis	1 eyes
Second Aqueous Shunt	Number of Eyes With Vision-threatening Complications	Ectropion	1 eyes
Second Aqueous Shunt	Number of Eyes With Vision-threatening Complications	Cystoid/Diabetic Macular Edema Progression	2 eyes
Second Aqueous Shunt	Number of Eyes With Vision-threatening Complications	Second Tube Migration Anteriorly	1 eyes
Second Aqueous Shunt	Number of Eyes With Vision-threatening Complications	Hypotony persistent	2 eyes
Second Aqueous Shunt	Number of Eyes With Vision-threatening Complications	Vitreous Clogging Second glaucoma drainage device	1 eyes
Second Aqueous Shunt	Number of Eyes With Vision-threatening Complications	Primary Tube Complications	2 eyes
Second Aqueous Shunt	Number of Eyes With Vision-threatening Complications	Intraocular Lens Dislocation	1 eyes
Second Aqueous Shunt	Number of Eyes With Vision-threatening Complications	Cataract Progression	0 eyes
Second Aqueous Shunt	Number of Eyes With Vision-threatening Complications	Phacodonesis	0 eyes
Second Aqueous Shunt	Number of Eyes With Vision-threatening Complications	Hyphema	2 eyes
Transscleral Cyclophotocoagulation	Number of Eyes With Vision-threatening Complications	Phacodonesis	1 eyes
Transscleral Cyclophotocoagulation	Number of Eyes With Vision-threatening Complications	Hyphema	0 eyes
Transscleral Cyclophotocoagulation	Number of Eyes With Vision-threatening Complications	Hypotony persistent	0 eyes
Transscleral Cyclophotocoagulation	Number of Eyes With Vision-threatening Complications	Choroidal Effusion	0 eyes
Transscleral Cyclophotocoagulation	Number of Eyes With Vision-threatening Complications	Cystoid/Diabetic Macular Edema Progression	3 eyes
Transscleral Cyclophotocoagulation	Number of Eyes With Vision-threatening Complications	Cataract Progression	3 eyes
Transscleral Cyclophotocoagulation	Number of Eyes With Vision-threatening Complications	Macular Hole	1 eyes
Transscleral Cyclophotocoagulation	Number of Eyes With Vision-threatening Complications	Herpes Simplex Keratitis	0 eyes
Transscleral Cyclophotocoagulation	Number of Eyes With Vision-threatening Complications	Ectropion	0 eyes
Transscleral Cyclophotocoagulation	Number of Eyes With Vision-threatening Complications	Second Tube Migration Anteriorly	0 eyes
Transscleral Cyclophotocoagulation	Number of Eyes With Vision-threatening Complications	Vitreous Clogging Second glaucoma drainage device	0 eyes
Transscleral Cyclophotocoagulation	Number of Eyes With Vision-threatening Complications	Intraocular Lens Dislocation	0 eyes
Transscleral Cyclophotocoagulation	Number of Eyes With Vision-threatening Complications	Primary Tube Complications	0 eyes

Secondary

Number of Office Visits Per Participant From Baseline to 3 Months

Time frame: from baseline to 3 months

Population: Data for this outcome measure were not collected 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Second Aqueous Shunt	Number of Office Visits Per Participant From Baseline to 3 Months	3.73 office visits per participant	Standard Deviation 2.53
Transscleral Cyclophotocoagulation	Number of Office Visits Per Participant From Baseline to 3 Months	0.95 office visits per participant	Standard Deviation 1.22

Secondary

Number of Office Visits Per Participant Per Month After Month 3

Time frame: from month 4 to year 3

Population: Data for this outcome measure were not collected for 2 in the Second Aqueous Shunt arm and 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Second Aqueous Shunt	Number of Office Visits Per Participant Per Month After Month 3	0.35 office visits per participant per month	Standard Deviation 0.34
Transscleral Cyclophotocoagulation	Number of Office Visits Per Participant Per Month After Month 3	0.13 office visits per participant per month	Standard Deviation 0.14

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.

Time frame: 1 month

Population: Data for this outcome measure were not collected for 2 in the Second Aqueous Shunt arm and 2 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Second Aqueous Shunt	Severity of Pain	1.40 score on a scale	Standard Deviation 2.23
Transscleral Cyclophotocoagulation	Severity of Pain	1.28 score on a scale	Standard Deviation 1.36

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.

Time frame: 1 week

Population: Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm and 2 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Second Aqueous Shunt	Severity of Pain	1.57 score on a scale	Standard Deviation 1.99
Transscleral Cyclophotocoagulation	Severity of Pain	1.44 score on a scale	Standard Deviation 1.5

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.

Time frame: baseline

Population: Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Arm	Measure	Value (MEAN)	Dispersion
Second Aqueous Shunt	Vision-related Quality of Life as Assessed by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 (NEI-VFQ-25) - General Health Subscale	62.5 score on a scale	Standard Deviation 21.5
Transscleral Cyclophotocoagulation	Vision-related Quality of Life as Assessed by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 (NEI-VFQ-25) - General Health Subscale	48.7 score on a scale	Standard Deviation 21.2

Secondary