TY - JOUR
T1 - One-year surgical outcomes of the PreserFlo MicroShunt in glaucoma
T2 - a multicentre analysis
AU - Tanner, Alexander
AU - Haddad, Fadi
AU - Fajardo-Sanchez, Julia
AU - Nguyen, Ethan
AU - Thong, Kai Xin
AU - Ah-Moye, Sarah
AU - Perl, Nicole
AU - Abu-Bakra, Mohammed
AU - Kulkarni, Avinash
AU - Trikha, Sameer
AU - Lascaratos, Gerassimos
AU - Parnell, Miles
AU - Kailani, Obeda
AU - King, Anthony J.
AU - Agrawal, Pavi
AU - Stead, Richard
AU - Giannouladis, Konstantinos
AU - Rodrigues, Ian
AU - Goyal, Saurabh
AU - Hysi, Pirro G.
AU - Lim, Sheng
AU - Yu-Wai-Man, Cynthia
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.
PY - 2022
Y1 - 2022
N2 - Background/aims: To evaluate the efficacy and safety of the PreserFlo MicroShunt glaucoma device in a multicentre cohort study. Methods: All consecutive patients who received the microshunt with mitomycin-C (MMC) 0.4 mg/mL from May 2019 to September 2020 in three UK tertiary centres. Primary outcome at 1 year was a complete success, with failure defined as intraocular pressure (IOP) >21 mmHg or <20% reduction, IOP≤5 mmHg with any decreased vision on two consecutive visits, reoperation or loss of light perception vision. Secondary outcomes were IOP, best-corrected visual acuity, medications, complications, interventions and reoperations. We also performed subgroup analyses for severe glaucoma and assessed risk factors for failure. Results: 104 eyes had 1-year follow-up. Complete and qualified success at 1 year were achieved in 51.9% (N=54) and 16.4% (N=17), respectively, and failure occurred in 31.7% (N=33). There was a significant reduction in IOP (mmHg) from preoperatively (23.4±0.8, N=104) to 12 months (14.7±0.6, N=104) (p<0.0001). Antiglaucoma medications also decreased from preoperatively (3.4±0.1, N=104) to 12 months (0.7±0.1, N=104) (p<0.0001). Multivariate analyses showed an association between higher mean deviation and failure (HR 1.055, 95% CI 1.0075 to 1.11, p=0.0227). Complications were hypotony (19.2%; N=20), choroidal detachments (10.6%; N=11), hyphaema (5.8%; N=6) and bleb leak (5.8%; N=6). Needling and 5-fluorouracil injections were performed in 12.5% (N=13) and 33.7% (N=35), respectively, and 11.5% (N=12) required revision surgery. Conclusion: The PreserFlo MicroShunt with MMC 0.4 mg/mL showed an overall success rate of 68.3% at 1 year, and led to significant IOP and medication reduction with a low rate of adverse effects.
AB - Background/aims: To evaluate the efficacy and safety of the PreserFlo MicroShunt glaucoma device in a multicentre cohort study. Methods: All consecutive patients who received the microshunt with mitomycin-C (MMC) 0.4 mg/mL from May 2019 to September 2020 in three UK tertiary centres. Primary outcome at 1 year was a complete success, with failure defined as intraocular pressure (IOP) >21 mmHg or <20% reduction, IOP≤5 mmHg with any decreased vision on two consecutive visits, reoperation or loss of light perception vision. Secondary outcomes were IOP, best-corrected visual acuity, medications, complications, interventions and reoperations. We also performed subgroup analyses for severe glaucoma and assessed risk factors for failure. Results: 104 eyes had 1-year follow-up. Complete and qualified success at 1 year were achieved in 51.9% (N=54) and 16.4% (N=17), respectively, and failure occurred in 31.7% (N=33). There was a significant reduction in IOP (mmHg) from preoperatively (23.4±0.8, N=104) to 12 months (14.7±0.6, N=104) (p<0.0001). Antiglaucoma medications also decreased from preoperatively (3.4±0.1, N=104) to 12 months (0.7±0.1, N=104) (p<0.0001). Multivariate analyses showed an association between higher mean deviation and failure (HR 1.055, 95% CI 1.0075 to 1.11, p=0.0227). Complications were hypotony (19.2%; N=20), choroidal detachments (10.6%; N=11), hyphaema (5.8%; N=6) and bleb leak (5.8%; N=6). Needling and 5-fluorouracil injections were performed in 12.5% (N=13) and 33.7% (N=35), respectively, and 11.5% (N=12) required revision surgery. Conclusion: The PreserFlo MicroShunt with MMC 0.4 mg/mL showed an overall success rate of 68.3% at 1 year, and led to significant IOP and medication reduction with a low rate of adverse effects.
KW - Glaucoma
KW - Intraocular pressure
KW - Treatment Surgery
KW - Wound healing
UR - http://www.scopus.com/inward/record.url?scp=85128671627&partnerID=8YFLogxK
U2 - 10.1136/bjophthalmol-2021-320631
DO - 10.1136/bjophthalmol-2021-320631
M3 - Article
C2 - 35365491
AN - SCOPUS:85128671627
SN - 0007-1161
JO - British Journal of Ophthalmology
JF - British Journal of Ophthalmology
M1 - bjophthalmol-2021-320631
ER -