Trial Outcomes & Findings for How Has Glaucoma Affected Your Quality of Life? (NCT NCT01476644)

Last Updated: 2019-11-15

Results Overview

National Eye Institute Visual Function-25 questionnaire (NEI VFQ-25) is a measurement of patients perception of their visually related quality of life. Patients select answers from multiple choice lists of responses. Values are re-coded and converted to a scale of 0 to 100 where 0 is extreme difficulty and 100 is no difficulty at all (or best quality of life). Data from visits 2 through 5.

Recruitment status

COMPLETED

Study phase

Target enrollment

161 participants

Primary outcome timeframe

2 hours at each annual visit, visits 2 through 5

Results posted on

2019-11-15

Participant Flow

Moderate glaucoma subjects recruited from the Glaucoma Service at Wills Eye Hospital, Philadelphia, Pennsylvania between May 2012 and May 2014 for an observational longitudinal study. One baseline and four annual visits were performed.

Participant milestones

Participant milestones
Measure	Participants With Moderate Glaucoma Participants with moderate glaucoma as defined by a disc damage likelihood scale (DDLS range 1 to 9) of the optic nerve between 5 and 8 in at least one eye. One on the DDLS corresponds to healthy optic nerve; 9 is advanced glaucoma damage.
Overall Study STARTED	161
Overall Study COMPLETED	122
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants With Moderate Glaucoma Participants with moderate glaucoma as defined by a disc damage likelihood scale (DDLS range 1 to 9) of the optic nerve between 5 and 8 in at least one eye. One on the DDLS corresponds to healthy optic nerve; 9 is advanced glaucoma damage.
Overall Study Death	5
Overall Study moved to another state	2
Overall Study Lost to Follow-up	19
Overall Study Withdrawal by Subject	13

Baseline Characteristics

How Has Glaucoma Affected Your Quality of Life?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort n=161 Participants Moderate glaucoma with a DDLS (optic disc damage likelihood scale range 1-10 with 10 being worse ) between 5 and 8 in at least one eye.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	85 Participants n=5 Participants
Age, Categorical >=65 years	76 Participants n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	159 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	52 Participants n=5 Participants
Race (NIH/OMB) White	96 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	161 Participants n=5 Participants
NEI-VFQ 25	83.5 units on a scale STANDARD_DEVIATION 14.3 • n=5 Participants
MGSS	83.7 units on a scale STANDARD_DEVIATION 13.1 • n=5 Participants

PRIMARY outcome

Timeframe: 2 hours at each annual visit, visits 2 through 5

Outcome measures

Outcome measures
Measure	Cohort n=161 Participants Moderate glaucoma participants based on a DDLS (disc damage likelihood scale, a grade of the health of the optic nerve) between 5 and 8 in at least one eye. DDLS score ranges from 1 to 10 with 10 being worst optic nerve.
Quality of Life With NEI VFQ-25 Visit 2	82.9 units on a scale Standard Deviation 13.6
Quality of Life With NEI VFQ-25 Visit 3	82.7 units on a scale Standard Deviation 14.7
Quality of Life With NEI VFQ-25 Visit 4	82.8 units on a scale Standard Deviation 13.5
Quality of Life With NEI VFQ-25 Visit 5	83.0 units on a scale Standard Deviation 14.8

SECONDARY outcome

Timeframe: 2 hours at each annual visit, visits 2 through 5

Modified Glaucoma Symptom Scale (MGSS), is patient perception of their eyes comfort. Ten ocular complaints often associated with glaucoma each have a four level score (1 signifying very bothersome; 4 represents absence of problems). Scores from 10 questions are added and range from 0 to 100 where 0 represents significant discomfort and 100 represents no problems at all. The final MGSS score is an unweighted average of responses to 10 items, averaged between the 2 eyes. Data from visits 2 through 5.

Outcome measures

Outcome measures
Measure	Cohort n=161 Participants Moderate glaucoma participants based on a DDLS (disc damage likelihood scale, a grade of the health of the optic nerve) between 5 and 8 in at least one eye. DDLS score ranges from 1 to 10 with 10 being worst optic nerve.
Eye Comfort With MGSS Visit 2	84.0 units on a scale Standard Deviation 12.6
Eye Comfort With MGSS Visit 3	84.5 units on a scale Standard Deviation 13.0
Eye Comfort With MGSS Visit 4	86.1 units on a scale Standard Deviation 10.9
Eye Comfort With MGSS Visit 5	85.0 units on a scale Standard Deviation 13.9

Adverse Events

Cohort

Serious events: 5 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Cohort n=161 participants at risk Moderate glaucoma as confirmed by a DDLS (disc damage likelihood scale, optic nerve health) between 5 and 8 in at least one eye. DDLS range 1 to 10 with 10 being worse optic nerve damage.
Investigations Death	3.1% 5/161 • Number of events 5 • 1 visit per year over 4 years

Other adverse events

Adverse event data not reported

Additional Information

George L. Spaeth, MD

Wills Eye Hospital, Glaucoma Research Center

Phone: 215-928-3123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place