PMID- 33315733
OWN - NLM
STAT- MEDLINE
DCOM- 20210727
LR  - 20210727
IS  - 1873-4502 (Electronic)
IS  - 0886-3350 (Linking)
VI  - 47
IP  - 7
DP  - 2021 Jul 1
TI  - Canaloplasty and trabeculotomy ab interno with the OMNI system combined with 
      cataract surgery in open-angle glaucoma: 12-month outcomes from the ROMEO study.
PG  - 907-915
LID - 10.1097/j.jcrs.0000000000000552 [doi]
AB  - PURPOSE: To provide safety and effectiveness outcomes 12 months postsurgically 
      for sequential canaloplasty and trabeculotomy with the OMNI system combined with 
      cataract surgery in mild-to-moderate open-angle glaucoma (OAG). SETTING: Eleven 
      ophthalmology practices and surgery centers located in 8 U.S. states. DESIGN: 
      Retrospective, multicenter, single arm. METHODS: Twelve surgeons contributed 81 
      patients meeting eligibility criteria: OAG, 12-month follow-up, and medicated 
      intraocular pressure (IOP) 36 mm Hg or less on 4 or less medications 
      preoperatively. Analysis was stratified by baseline IOP: more than 18 mm Hg 
      (Group 1) and 18 mm Hg (Group 2) or less. Success was defined as proportion with 
      20% reduction or greater in IOP or IOP between 6 and 18 mm Hg (inclusive) and on 
      the same or fewer medications without secondary surgical intervention (SSI). 
      Other endpoints included mean IOP and medications at 12 months. Safety included 
      corrected distance visual acuity and adverse events (AEs). RESULTS: Of the 81 
      patients included, primary success was met by 79% in Group 1 and 81% in Group 2. 
      The mean IOP was reduced in Group 1 (21.9 to 15.1 mm Hg, P < .0001) and remained 
      controlled in Group 2 (14.1 to 13.4 mm Hg, P = .3177). Medications went from 2.0 
      +/- 1.3 to 1.1 +/- 1.1 in Group 1 and from 1.6 +/- 1.3 to 0.9 +/- 1.2 in Group 2. AEs 
      were typical for cataract or angle surgery: mild inflammation (11%), IOP spikes 
      (5%), and hyphema (4%). Four patients (5%) required an SSI. CONCLUSIONS: The OMNI 
      system provided effective IOP reduction, sustained IOP control, and meaningful 
      medication reduction for up to 12 months postoperative.
CI  - Copyright (c) 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on 
      behalf of ASCRS and ESCRS.
FAU - Hirsch, Louis
AU  - Hirsch L
AD  - From the Mercy Eye Specialists, Springfield, Missouri (Hirsch); Columbia 
      University Medical Center, New York, New York (Cotliar); Arthur M Cotliar Eye 
      Care and Surgery, New York, New York (Cotliar, Ferreira); Vold Vision, 
      Fayetteville, Arkansas (Vold); Ophthalmology Associates of Western New York, 
      Williamsville, New York (Selvadurai); Grene Vision Group, Wichita, Kansas 
      (Campbell); Morris Eye Group, Encinitas, California (Aminlari); Serrano Eye 
      Center Medical Group, Los Angeles, California (Cho); Eye Center South, Dothan, 
      Alabama (Heersink); private practice, Laredo, Texas (Hochman); El Paso Eye 
      Surgeons, PA, El Paso, Texas (Gallardo); Department of Ophthalmology, University 
      of Texas Health Sciences Center, San Antonio, Texas (Gallardo); The Williamson 
      Eye Center, Baton Rouge, Louisiana (Williamson, Nelson); Nassau University 
      Medical Center, East Meadow, New York (Phan); North Texas Eye Research Institute, 
      University of North Texas Health Science Center, Fort Worth, Texas (Dickerson); 
      Sight Sciences, Inc, Menlo Park, California (Dickerson).
FAU - Cotliar, Jeremy
AU  - Cotliar J
FAU - Vold, Steven
AU  - Vold S
FAU - Selvadurai, Deepan
AU  - Selvadurai D
FAU - Campbell, Anita
AU  - Campbell A
FAU - Ferreira, Gabriel
AU  - Ferreira G
FAU - Aminlari, Ardalan
AU  - Aminlari A
FAU - Cho, Andrew
AU  - Cho A
FAU - Heersink, Sebastian
AU  - Heersink S
FAU - Hochman, Michael
AU  - Hochman M
FAU - Gallardo, Mark
AU  - Gallardo M
FAU - Williamson, Blake
AU  - Williamson B
FAU - Phan, Ryan
AU  - Phan R
FAU - Nelson, Cade
AU  - Nelson C
FAU - Dickerson, Jaime E Jr
AU  - Dickerson JE Jr
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PL  - United States
TA  - J Cataract Refract Surg
JT  - Journal of cataract and refractive surgery
JID - 8604171
SB  - IM
MH  - *Cataract/complications
MH  - *Glaucoma, Open-Angle/surgery
MH  - Humans
MH  - Intraocular Pressure
MH  - *Ophthalmology
MH  - Retrospective Studies
MH  - *Trabeculectomy
MH  - Treatment Outcome
EDAT- 2020/12/15 06:00
MHDA- 2021/07/28 06:00
CRDT- 2020/12/14 17:13
PHST- 2020/07/31 00:00 [received]
PHST- 2020/12/07 00:00 [accepted]
PHST- 2020/12/15 06:00 [pubmed]
PHST- 2021/07/28 06:00 [medline]
PHST- 2020/12/14 17:13 [entrez]
AID - 02158034-202107000-00014 [pii]
AID - 10.1097/j.jcrs.0000000000000552 [doi]
PST - ppublish
SO  - J Cataract Refract Surg. 2021 Jul 1;47(7):907-915. doi: 
      10.1097/j.jcrs.0000000000000552.