Early Experience with the New XEN63 Implant in Primary Open-Angle Glaucoma Patients: Clinical Outcomes
Abstract
:1. Introduction
2. Materials and Methods
2.1. Design
2.2. Patients
2.3. Device
2.4. Surgical Technique
2.5. Outcomes
2.6. Statistical Analysis
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variable | Overall (n = 23) | XEN 63 (n = 20) | Phaco + XEN63 (n = 3) |
---|---|---|---|
Age, years | |||
Mean ± SD | 67.8 ± 15.3 | 67.3 ± 15.9 | 71.3 ± 12.4 |
Sex, n (%) | |||
Women Men | 15 (65.2) 8 (34.8) | 14 (70.0) 6 (30.0) | 1 (33.3) 2 (66.7) |
Type of glaucoma | |||
POAG Uveitic PXG PACG Traumatic Missing information | 14 (60.9) 4 (17.4) 1 (4.3) 1 (4.3) 1 (4.3) 2 (8.7) | 12 (60.0) 3 (15.0) 1 (5.0) 1 (5.0) 1 (5.0) 2 (10.0) | 2 (66.7) 1 (33.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) |
Previous laser, n (%) | |||
No SLT Nd:YAG Iridotomy | 21 (91.3) 1 (4.3) 1 (4.3) | 18 (90.0) 1 (5.0) 1 (5.0) | 3 (100.0) 0 (0.0) 0 (0.0) |
Previous surgery *, n (%) | |||
None Cataract Refractive (laser) Trabecular MIG Subconjunctival MIG | 2 (8.7) 14 (60.9) 3 (13.0) 2 (8.7) 2 (8.7) | 0 (0.0) 14 (70.0) 3 (15.0) 2 (10.0) 2 (10.0) | 3 (100.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) |
BCVA, ETDRS | |||
Mean ± SD | 0.49 ± 0.26 | 0.54 ± 0.24 | 0.23 ± 0.15 |
ECC | |||
Mean ± SD | 2217.9 ± 343.1 | 2223.4 ± 297.0 | 2161.0 ± 563.8 |
MD, dB | |||
Mean ± SD | −17.03 ± 9.96 | −16.71 ± 10.51 | −18.23 ± 9.44 |
PSD, dB | |||
Mean ± SD | 7.00 ± 2.28 | 7.10 ± 3.08 | 6.66 ± 3.2 |
NTOHM | |||
Mean ± SD | 2.27 ± 0.94 | 2.26 ± 0.99 | 2.33 ± 0.58 |
IOP, mm Hg | |||
Mean ± SD | 27.0 ± 7.8 | 26.5 ± 8.2 | 30.3 ± 3.2 |
Day 1 | Day 7 | Month 1 | Month 3 | |
---|---|---|---|---|
Worse ≥2 lines, n (%) | 4 (17.4) | 4 (17.4) | 2 (8.7) | 2 (8.7) |
Worse ≥1 line, n (%) | 6 (26.1) | 7 (30.4) | 3 (13.0) | 3 (13.0) |
Unchanged, n (%) | 9 (39.1) | 6 (26.1) | 8 (34.8) | 6 (26.1) |
Improvement ≥1 line, n (%) | 0 (0.0) | 2 (8.7) | 3 (13.0) | 2 (8.7) |
Improvement ≥2 lines, n (%) | 4 (17.4) | 4 (17.4) | 7 (30.4) | 8 (34.8) |
Study | MMC | Type of Glaucoma | Baseline IOP, mm Hg | M3 IOP, mm Hg | IOP Lowering (%) | IOP Lowering, mm Hg | Mean Preoperative Medications | Mean Postoperative Medications at M3 | Needling Rates at the End of the Study, n (%) |
---|---|---|---|---|---|---|---|---|---|
Reitsamer et al. [13] | 10–80 µg/mL 1 | POAG | 21.4 (3.6) * | 15.7 † | −25.0 † | N.A. | 2.7 (0.9) | 0.5 (0.9) | 83 (41.1) |
Marcos-Parra et al. [15] | 10 µg/mL | OAG 3 | 19.1 (5.4) * | N.A. | N.A. | −6.1 (−9.9 to −0.1) ** | 2.5 (0.8) | N.A. | 13 (20.0) |
Fea et al. [16] | 20 µg/mL | OAG 3 | 23.9 (7.6) * | 15.1 † | N.A. | N.A. | 3.0 (1.0) | 0.4 † | 79 (46.2) |
Grover et al. [24] | 20 µg/mL 2 | Refractory OAG 3 | 25.1 (3.7) * | 16.6 (5.5) * | −32.7 † | −8.5 † | 3.5 (1.0) | 0.5 † | 21 (32.3) |
Ibáñez-Muñoz et al. [25] | 10 µg/mL | OAG 3 | 22.8 (20.8 to 24.7) ** | 16.4 (14.3 to 18.5) ** | N.A. | N.A. | 3.4 (0.8) | N.A. | 19 (26.0) |
Laborda-Guirao et al. [26] | 20 µg/mL | OAG 3 | 21.0 (5.2) * | 14.5 (13.6 to 15.4) ** | N.A. | −6.7 (−8.8 to −4.6) | 2.8 (2.7 to 3.0) ** | N.A. | 7 (8.8) |
Theilig et al. [27] | 10 µg/mL | POAG | 24.5 (6.7) * | 16.8 (6.3) | N.A. | N.A. | 3.0 (1.1) * | 1.1 (1.4) * | 42 (42.0) |
Hengerer et al. [28] | 10 µg/mL | OAG 4 | 32.2 (9.1) * | 14.6 † | N.A. | N.A. | 3.1 (1.0) * | −2.7 (1.2) ‡ | 67 (27.7) *** |
Current study | 20–30 µg/mL 1 | OAG 3 | 27.0 (7.8) * | 12.2 (3.4) * | −40.8 (23.5) * | −14.8 (−20.1 to −9.5) ** | 2.3 (0.9) * | 0.1 (0.4) * | 3 (13.0) |
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Fea, A.M.; Menchini, M.; Rossi, A.; Posarelli, C.; Malinverni, L.; Figus, M. Early Experience with the New XEN63 Implant in Primary Open-Angle Glaucoma Patients: Clinical Outcomes. J. Clin. Med. 2021, 10, 1628. https://doi.org/10.3390/jcm10081628
Fea AM, Menchini M, Rossi A, Posarelli C, Malinverni L, Figus M. Early Experience with the New XEN63 Implant in Primary Open-Angle Glaucoma Patients: Clinical Outcomes. Journal of Clinical Medicine. 2021; 10(8):1628. https://doi.org/10.3390/jcm10081628
Chicago/Turabian StyleFea, Antonio Maria, Martina Menchini, Alessandro Rossi, Chiara Posarelli, Lorenza Malinverni, and Michele Figus. 2021. "Early Experience with the New XEN63 Implant in Primary Open-Angle Glaucoma Patients: Clinical Outcomes" Journal of Clinical Medicine 10, no. 8: 1628. https://doi.org/10.3390/jcm10081628