24-Month Outcomes of Ahmed ClearPath^® Glaucoma Drainage Device for Refractory Glaucoma

Figures & data

Table 1 Demographic and Baseline Glaucoma Status of Study Participants

Parameter	Value
No. of patients, n	11
Age (yr), mean (SD)	71.3 (14.1)
Gender, n (%)
Male	1 (9.1)
Female	10 (90.9)
Ethnicity, n (%)
White	8 (72.7)
Black	2 (18.2)
Asian	1 (9.1)
No. of eyes, n	12
Diagnosis, n (%)
Primary open-angle glaucoma	12 (100)
Glaucoma severity, n (%)
Severe	12 (100)
Lens status, n (%)
Phakic	1 (8.3)
Pseudophakic	11 (91.7)
Laterality, n (%)
Right eye	6 (50.0)
Left eye	6 (50.0)
Previous Glaucoma Procedures, n (%)
Any	10 (83.3)
MicroPulse cyclophotocoagulation	7 (58.3)
Xen gel stent implant	4 (33.3)
Selective laser trabeculoplasty	2 (16.7)
Trabeculectomy	1 (8.3)
Cypass implant	1 (8.3)
No previous glaucoma procedures	2 (16.7)

Table 2 Mean IOP and Medication Use at Each Study Visit

	Baseline	1 Day	1 Week	1 Month	3 Months	6 Months	12 Months	18 Months	24 Months	Last Follow-up
Number of eyes, n	12	12	12	12	9	12	7	7	5	12
Intraocular pressure, mmHg
Mean (SD)	29.0 (7.6)	6.9 (4.0)	5.9 (2.6)	10.8 (2.9)	10.8 (3.0)	11.2 (3.9)	10.0 (3.1)	12.3 (4.3)	11.2 (4.7)	12.2 (4.0)
Change from baseline		−76.1%	−79.6%	−62.7%	−62.8%	−61.5%	−65.5%	−57.6%	−61.4%	−58.0%
Significance (P)		<0.0001	<0.0001	<0.0001	<0.0001	<0.0001	0.0008	0.001	0.029	<0.0001
Medications, n
Mean (SD)	3.0 (0.9)	0.3 (0.7)	0.2 (0.6)	0.3 (0.7)	0.9 (0.9)	0.7 (0.9)	0.6 (0.8)	0.7 (0.9)	0.6 (0.5)	0.5 (0.7)
Change from baseline		−88.9%	−91.7%	−88.9%	−70.4%	−77.8%	−81.0%	−76.2%	−80.0%	−83.3%
Significance (P)		<0.0001	<0.0001	<0.0001	0.0005	<0.0001	0.0047	0.0038	0.0029	<0.0001

Figure 1 Mean IOP over time in the study cohort. Error bars represent standard deviation. Reductions from baseline were significant (p<0.05) at every time point.

Table 3 Secondary Outcome Measures at Last Mean Follow-Up (n = 12 Eyes)

Secondary Outcome	Incidence, n (%)
Proportion achieving an IOP between 6–19 mmHg	11 (91.7)
Proportion achieving IOP reduction of ≥ 20%,	12 (100)
Proportion achieving reduction by ≥1 medications	11 (91.7)

Figure 2 Mean medication use over time in the study cohort. Error bars represent standard deviation. Reductions from baseline were significant (p<0.05) at every time point.

Table 4 The Nature and Frequency of Postoperative Complications (n = 12 Eyes)

Event	Incidence, n (%)
Hyphema	4 (33.3)
Anterior chamber inflammation	2 (16.7)
Pain (mild)	3 (25.0)
Shallow anterior chamber	1 (8.3)

Figure 3 A shallow, diffuse bleb was observed in all eyes (n = 12) at the 24-month follow-up visits.