Long-term (60-month) results for the implantable miniature telescope: efficacy and safety outcomes stratified by age in patients with end-stage age-related macular degeneration

Figures & data

Table 1 Best-corrected distance visual acuity in implanted with the implantable miniature telescope, stratified by age group

	12 months	24 months	36 months	48 months	60 months
Age 65 to <75 years (group 1)
n	65	60	22	38	31
Gain ≥3 lines	43 (66.2%)	37 (61.7%)	11 (50.0%)	22 (57.9%)	18 (58.1%)
Gain ≥2 lines	52 (80.0%)	45 (75.0%)	15 (68.2%)	26 (68.4%)	21 (67.7%)
Mean ± SD line change	3.6±2.1 lines	3.3±2.0 lines	2.4±2.8 lines	2.7±2.6 lines	2.7±2.7 lines
Age ≥75 years (group 2)
n	109	95	42	46	32
Gain ≥3 lines	72 (66.1%)	55 (57.9%)	24 (57.1%)	19 (41.3%)	12 (37.5%)
Gain ≥2 lines	87 (79.8%)	71 (74.7%)	31 (73.8%)	29 (63.0%)	19 (59.4%)
Mean ± SD line change	3.4±2.2 lines	3.1±2.2 lines	3.0±1.8 lines	2.2±2.6 lines	2.1±2.9 lines

Abbreviation: SD, standard deviation.

Table 2 Vision loss stratified by age group

	12 months	24 months	36 months	48 months	60 months
Age 65 to <75 years (group 1)
n	65	60	22	38	31
Loss ≥2 lines	1 (1.5%)	0 (0.0%)	2 (9.1%)	2 (5.3%)	3 (9.4%)
Age ≥75 years (group 2)
n	109	95	42	46	32
Loss ≥2 lines	2 (1.8%)	2 (2.1%)	0 (0.0%)	2 (4.3%)	3 (9.4%)
Fellow (non-implanted) eyes
Age 65 to <75 years (group 1)
n	65	60	22	38	31
Loss ≥2 lines	4 (6.2%)	3 (5.0%)	2 (9.1%)	4 (10.5%)	5 (16.1%)
Age ≥75 years (group 2)
n	109	95	42	46	32
Loss ≥2 lines	10 (9.2%)	12 (12.5%)	6 (14.3%)	6 (13.0%)	9 (28.1%)

Table 3 Results for quality of life questionnaire

NEI VFQ-25 subscale*	Age 65 to <75 years (group 1)	Age ≥75 years (group 2)
	Change from preoperative mean score (95% CI) n=65	Change from preoperative mean score (95% CI) n=109
General vision	20 (14, 26)	9 (5, 13)
Near activities	14 (9, 20)	8 (5, 12)
Distance activities	12 (6, 17)	5 (0, 9)
Color vision	6 (0, 12)	1 (−4, 6)
Social functioning	17 (6, 21)	6 (1, 10)
Mental health	15 (10, 21)	5 (1, 9)
Role difficulties	16 (10, 22)	3 (−1, 8)
Dependency	13 (6, 19)	7 (2, 12)
Ocular pain	3 (−1, 8)	−1 (−4, 3)
Driving	0 (−1, 2)	−1 (−3, 0)
Peripheral vision	−8 (−16, 0)	−4 (−10, 2)
Overall composite	10 (6, 13)	3 (1, 6)

Note:

* Not all patients completed the questionnaire.

Abbreviations: NEI, National Eye Institute; CI, confidence interval; VFQ-25, Visual Function Questionnaire 25-item.

Table 4 Significant ocular complications in the operated eye through 60 months

Significant ocular complications	Age 65 to <75 years (group 1; n=70)		Age ≥75 years (group 2; n=127)
	n	%	n	%
Aborted surgery	0	0.0	5	3.9
Choroidal detachment	0	0.0	2	1.6
Choroidal hemorrhage	0	0.0	1	0.8
Corneal edema ≤30 days after surgery	3	4.3	10	7.9
Iris atrophy ≤7 days after surgery	1	1.4	3	2.4
Iris damage	4	5.7	5	3.9
Iris incarceration	1	1.4	2	1.6
Iris prolapse	6	8.6	6	4.7
Iris transillumination defects ≤21 days after surgery	0	0.0	7	5.5
Phthisis	0	0.0	1	0.8
Posterior capsular rupture	1	1.4	6	4.7
Vitreous hemorrhage ≤7 days after surgery	0	0.0	1	0.8
Vitreous in anterior chamber ≤7 days after surgery	0	0.0	3	2.4
Vitreous loss	0	0.0	3	2.4
Vitreous loss – vitrectomy required	1	1.4	5	3.9

Table 5 Significant adverse events in operated eyes through 60 months

Significant adverse events	Age 65 to <75 years (group 1; n=70)		Age ≥75 years (group 2; n=127)
	n	%	n	%
Choroidal neovascularization	0	0.0	4	3.1
Corneal edema >30 days after surgery	4	5.7	9	7.1
Corneal transplant (subset of persistent vision-impairing corneal edema)	2	2.9	2	1.6
Decrease >2 lines BCDVA in telescope-implanted eye	4	5.7	10	7.9
Device failure	0	0.0	2	1.6
Endophthalmitis	0	0.0	0	0.0
Iris atrophy >7 days after surgery	2	2.9	6	4.7
Iritis >30 days after surgery	7	10.0	5	3.9
Persistent unresolved corneal edema (subset of corneal edema >30 days after surgery)	3	4.3	6	4.7
Persistent vision-impairing corneal edema (subset of persistent unresolved corneal edema)	3	4.3	4	3.1
Retinal detachment	0	0.0	0	0.0
Retinal tear	0	0.0	0	0.0
Subretinal hemorrhage	0	0.0	5	3.9
Telescope dislocation	0	0.0	3	2.4
Telescope removal	1	1.4	10	7.9
Vitreous hemorrhage >7 days after surgery	1	1.4	2	1.6
Vitreous in anterior chamber >7 days after surgery	1	1.4	4	3.1

Abbreviation: BCDVA, best corrected distance visual acuity.

Table 6 Visual acuity loss in the nonimplanted eyes through month 60

	Age 65 to <75 years (n=70)		Age ≥75 years (n=127)
	n	%	n	%
Decrease >2 lines in BCDVA in nonimplanted fellow eye	7	10.0	24	18.9

Abbreviation: BCDVA, best corrected distance visual acuity.

Table 7 Corneal endothelial cell density in implanted eyes through month 60 in IMT-002-LTM

	Baseline	3 months	12 months	24 months	36 months	48 months	60 months
Age 65 to <75 years (group 1)
n	68	65	65	59	22	35	28
Mean ECD	2,444	1,984	1,866	1,775	1,569	1,618	1,552
95% CI	2,362, 2,525	1,849, 2,118	1,731, 2,002	1,637, 1,914	1,323, 1,815	1,429, 1,808	1,325, 1,779
Mean change in ECD		−18%	−23%	−27%	−33%	−32%	−35%
95% CI		−23, −13	−28, −18	−32, −21	−43, −24	−39, −25	−44, −27
Age ≥75 years (group 2)
n	119	111	102	94	39	42	29
Mean ECD	2,499	1,957	1,823	1,762	1,677	1,579	1,576
95% CI	2,433, 2,564	1,843, 2,072	1,703, 1,943	1,631, 1,893	1,475, 1,880	1,385, 1,772	1,333, 1,819
Mean change in ECD		−22%	−28%	−30%	−34%	−38%	−40%
95% CI		−26, −18	−32, −24	−35, −25	−41, −27	−45, −31	−48, −32

Note: Not all patients were available for all follow-up visits.

Abbreviations: CI, confidence interval; ECD, endothelial cell density.