PRESERFLO™ Microshunt: 1-Year Results of a 25-Gauge vs. 27-Gauge Needle Tract
Abstract
1. Introduction
2. Materials and Methods
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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All | 25-Gauge | 27-Gauge | p-Value | |
---|---|---|---|---|
n = 60 | n = 19 | n = 41 | ||
Age (years). median (IQR) | 72 (58–79) | 74 (57–81) | 71 (58–79) | 0.251 |
Sex. n (%) | 0.511 | |||
Female | 29 (48) | 8 (42) | 21 (51) | |
Eye. n (%) | 0.896 | |||
Left | 34 (57) | 11 (58) | 23 (56) | |
Glaucoma type. n (%) | 0.635 | |||
Primary open-angle glaucoma | 29 (48) | 10 (53) | 19 (46) | |
Pseudoexfoliative glaucoma | 15 (25) | 5 (26) | 10 (24) | |
Pigment dispersion glaucoma | 4 (7) | 0 (0) | 4 (10) | |
Primary angle-closure glaucoma | 1 (2) | 0 (0) | 1 (2) | |
Other * | 11 (18) | 4 (21) | 7 (17) | |
History of glaucoma surgery. n (%) | 13 (22) | 2 (11) | 11 (27) | 0.154 |
Trabeculectomy | 8 (13) | 1 (5) | 7 (17) | |
Xen | 5 (8) | 1 (5) | 4 (10) | |
Lens status. n (%) | 0.967 | |||
Pseudophakic | 16 (27) | 5 (26) | 11 (27) |
All n = 60 | 25-Gauge n = 19 | 27-Gauge n = 41 | p-Value | ||
---|---|---|---|---|---|
Pre OP | IOP (mmHg) | 23.4 ± 8.6 | 24.2 ± 7.3 | 23.1 ± 9.2 | 0.639 |
GDS | 3.1 ± 0.9 | 3.0 ± 0.8 | 3.1 ± 1.0 | 0.701 | |
n | 60 | 19 | 41 | ||
Day 1–2 | IOP (mmHg) | 10.6 ± 7.0 | 10.1 ± 4.3 | 10.9 ± 8.2 | 0.717 |
GDS | 0.1 ± 0.5 | 0.0 ± 0.0 | 0.2 ± 0.6 | 0.247 | |
n | 49 | 18 | 31 | ||
Week 1 | IOP (mmHg) | 11.6 ± 5.7 | 10.1 ± 3.5 | 12.2 ± 6.3 | 0.238 |
GDS | 0.1 ± 0.6 | 0.0 ± 0.0 | 0.2 ± 0.7 | 0.283 | |
n | 49 | 15 | 34 | ||
Week 2 | IOP (mmHg) | 11.3 ± 6.7 | 10.2 ± 4.8 | 11.7 ± 7.4 | 0.499 |
GDS | 0.2 ± 0.7 | 0.0 ± 0.0 | 0.3 ± 0.8 | 0.264 | |
n | 42 | 13 | 29 | ||
Month 1 | IOP (mmHg) | 12.1 ± 4.4 | 10.6 ± 3.3 | 12.8 ± 4.7 | 0.072 |
GDS | 0.1 ± 0.4 | 0.1 ± 0.2 | 0.2 ± 0.5 | 0.315 | |
n | 58 | 18 | 30 | ||
Month 3 | IOP (mmHg) | 12.4 ± 3.2 | 11.2 ± 3.0 | 13.0 ± 3.2 | 0.061 |
GDS | 0.2 ± 0.6 | 0.0 ± 0.1 | 0.3 ± 0.7 | 0.192 | |
n | 52 | 16 | 36 | ||
Month 6 | IOP (mmHg) | 14.3 ± 4.0 | 13.5 ± 4.2 | 14.8 ± 3.8 | 0.267 |
GDS | 0.6 ± 1.0 | 0.3 ± 0.7 | 0.8 ± 1.1 * | 0.046 | |
n | 48 | 17 | 31 | ||
Year 1 | IOP (mmHg) | 15.1 ± 5.9 | 12.7 ± 2.7 | 16.2 ± 6.7 * | 0.035 |
GDS | 0.8 ± 1.1 | 0.5 ± 0.8 | 0.9 ± 1.2 | 0.137 | |
n | 60 | 19 | 41 |
Overall | 25-Gauge | 27-Gauge | p-Value | Stand-Alone Surgery | Combined Surgery | p-Value | |
---|---|---|---|---|---|---|---|
Mean Survival | Mean Survival | Mean Survival | Mean Survival | Mean Survival | |||
n = 60 | n = 19 | n = 41 | n = 51 | n = 9 | |||
QS21 | 359 (313–404) | 448 (385–511) | 308 (254–361) * | 0.005 | 344 (295–393) | 435 (339–532) | 0.192 |
QS18 | 352 (308–397) | 448 (385–511) | 300 (250–352) * | 0.002 | 340 (292–389) | 421 (327–515) | 0.296 |
FS21 | 315 (268–361) | 398 (330–467) | 270 (215–325) * | 0.010 | 299 (251–347) | 377 (259–496) | 0.274 |
FS18 | 311 (265–357) | 396 (327–466) | 266 (212–319) * | 0.007 | 298 (249–346) | 361 (248–475) | 0.455 |
Covariates | QS21 | FS18 | |||
---|---|---|---|---|---|
n | Hazard Ratio (95% CI) | p-Value | Hazard Ratio (95% CI) | p-Value | |
Age | 60 | 1.02 (0.98–1.07) | 0.308 | 1.02 (0.98–1.06) | 0.274 |
Sex: Male | 31 | 1.00 (0.43–2.30) | 0.994 | 0.82 (0.39–1.73) | 0.596 |
Baseline IOP | 60 | 1.03 (0.96–1.11) | 0.452 | 1.04 (0.97–1.12) | 0.244 |
Baseline number of glaucoma medication | 60 | 0.85 (0.50–1.45) | 0.560 | 0.95 (0.58–1.55) | 0.828 |
Diagnosis: Primary open angle | 28 | Reference | Reference | ||
Diagnosis: PEX | 15 | 0.72 (0.23–2.28) | 0.579 | 0.60 (0.20–1.79) | 0.356 |
Diagnosis: Pigmentary glaucoma | 4 | 3.48 (0.63–19.17) | 0.152 | 2.92 (0.60–14.12) | 0.183 |
Diagnosis: Other | 12 | 0.37 (0.13–1.03) | 0.058 | 0.34 (0.13–0.92) | 0.033 |
Glaucoma surgery prior to PMS | 13 | 2.42 (0.97–6.08) | 0.059 | 2.65 (1.12–6.23) | 0.026 |
Combined PMS with cataract extraction | 9 | 0.47 (0.13–1.70) | 0.248 | 0.81 (0.28–2.32) | 0.692 |
Conjunctival opening: Limbus based | 23 | 1.23 (0.46–3.33) | 0.678 | 1.11 (0.45–2.76) | 0.815 |
Needle diameter: 25G | 19 | 0.47 (0.24–0.90) | 0.022 | 0.48 (0.27–0.86) | 0.013 |
Number of created tunnels | 60 | 1.28 (0.76–2.14) | 0.360 | 1.12 (0.67–1.87) | 0.658 |
All | 25-Gauge | 27-Gauge | p-Value | |
---|---|---|---|---|
n = 60 | n = 19 | n = 41 | ||
Transient ocular hypotension | 13 (21) | 7 (37) | 6 (15) | 0.089 |
Clinically relevant ocular hypotension | 4 (7) | 4 (21) | 0 (0) * | 0.008 |
Shallowing of the anterior chamber | 1 (2) | 1 (5) | 0 (0) | 0.317 |
Choroidal effusion | 5 (8) | 4 (21) | 1 (2) * | 0.031 |
Wound dehiscence | 1 (2) | 0 (0) | 1 (2) | 0.683 |
Hyphema | 1 (2) | 0 (0) | 1 (2) | 0.683 |
Device touch to the iris | 1 (2) | 1 (5) | 0 (0) | 0.317 |
Device dislocation | 1 (2) | 1 (5) | 0 (0) | 0.317 |
One of the recorded complications | 18 (30) | 10 (53) | 8 (20) * | 0.015 |
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Steiner, S.; Resch, H.; Kiss, B.; Vass, C. PRESERFLO™ Microshunt: 1-Year Results of a 25-Gauge vs. 27-Gauge Needle Tract. J. Clin. Med. 2024, 13, 1979. https://doi.org/10.3390/jcm13071979
Steiner S, Resch H, Kiss B, Vass C. PRESERFLO™ Microshunt: 1-Year Results of a 25-Gauge vs. 27-Gauge Needle Tract. Journal of Clinical Medicine. 2024; 13(7):1979. https://doi.org/10.3390/jcm13071979
Chicago/Turabian StyleSteiner, Stefan, Hemma Resch, Barbara Kiss, and Clemens Vass. 2024. "PRESERFLO™ Microshunt: 1-Year Results of a 25-Gauge vs. 27-Gauge Needle Tract" Journal of Clinical Medicine 13, no. 7: 1979. https://doi.org/10.3390/jcm13071979
APA StyleSteiner, S., Resch, H., Kiss, B., & Vass, C. (2024). PRESERFLO™ Microshunt: 1-Year Results of a 25-Gauge vs. 27-Gauge Needle Tract. Journal of Clinical Medicine, 13(7), 1979. https://doi.org/10.3390/jcm13071979