PMID- 33045423
OWN - NLM
STAT- MEDLINE
DCOM- 20211028
LR  - 20211028
IS  - 2589-4196 (Electronic)
IS  - 2589-4196 (Linking)
VI  - 4
IP  - 2
DP  - 2021 Mar-Apr
TI  - Canaloplasty and Trabeculotomy with the OMNI System in Pseudophakic Patients with 
      Open-Angle Glaucoma: The ROMEO Study.
PG  - 173-181
LID - S2589-4196(20)30264-7 [pii]
LID - 10.1016/j.ogla.2020.10.001 [doi]
AB  - PURPOSE: Provide outcomes up to 12 months postsurgically for sequential 
      canaloplasty and trabeculotomy with the OMNI surgical system (Sight Sciences, 
      Inc) in pseudophakic patients with mild to moderate open-angle glaucoma. DESIGN: 
      Retrospective, multicenter, single-arm study conducted at 10 multi-subspecialty 
      ophthalmology practices and surgery centers located in 7 states (Arkansas, 
      California, Kansas, Louisiana, Missouri, New York, and Texas). PARTICIPANTS: 
      Eligible patients were pseudophakic, with mild/moderate open-angle glaucoma, 
      12-month follow-up, and medicated intraocular pressure (IOP) </=36 mmHg on </=4 
      medications preoperatively. One eye per patient was enrolled. METHODS: 
      Institutional Review Board approved. All available cases meeting eligibility 
      criteria were enrolled. Analysis of secondary end points was stratified by 
      baseline (BL) IOP (>18 mmHg in group 1 and </=18 mmHg in group 2) recognizing that 
      treatment goals differed depending on BL IOP. MAIN OUTCOME MEASURES: Primary 
      success was defined as the proportion of patients with >/=20% reduction in IOP from 
      BL or IOP between 6 and 18 mmHg (inclusive) and on the same or fewer medications 
      without secondary surgical intervention (SSI). Other effectiveness end points 
      included mean IOP and number of medications at 12 months. Safety end points were 
      best-corrected visual acuity (BCVA), adverse events (AEs), and SSIs. RESULTS: 
      Forty-eight patients were enrolled, 24 in each group. Primary success was met by 
      73%. Mean IOP was reduced in group 1 (21.8 to 15.6 mmHg, P < 0.0001) and remained 
      controlled in group 2 (15.4 to 13.9 mmHg, P = 0.24). Medications went from 1.7 +/- 
      1.3 to 1.2 +/- 1.3 (P = 0.024) in group 1 and from 2.0 +/- 1.3 to 1.3 +/- 1.3 
      (P = 0.003) in group 2. Adverse events were typical for the patient population 
      undergoing angle surgery. Those reasonably related to the procedure were mild 
      inflammation (13%), IOP spikes (6%), hyphema, corneal edema, and BCVA loss (all 
      4%). Five patients (10%) required an SSI. CONCLUSIONS: The sequential combination 
      of canaloplasty followed by trabeculotomy performed as stand-alone procedures 
      using the OMNI system in pseudophakic patients with open-angle glaucoma provides 
      effective IOP reduction or sustained IOP control and meaningful medication 
      reduction for up to 12 months postoperatively.
CI  - Copyright (c) 2020 American Academy of Ophthalmology. Published by Elsevier Inc. 
      All rights reserved.
FAU - Vold, Steven D
AU  - Vold SD
AD  - Vold Vision, Fayetteville, Arkansas.
FAU - Williamson, Blake K
AU  - Williamson BK
AD  - The Williamson Eye Center, Baton Rouge, Louisiana.
FAU - Hirsch, Louis
AU  - Hirsch L
AD  - Mercy Eye Specialists, Springfield, Missouri.
FAU - Aminlari, Ardalan E
AU  - Aminlari AE
AD  - Morris Eye Group, Encinitas, California.
FAU - Cho, Andrew S
AU  - Cho AS
AD  - Serrano Eye Center Medical Group, Los Angeles, California.
FAU - Nelson, Cade
AU  - Nelson C
AD  - The Williamson Eye Center, Baton Rouge, Louisiana.
FAU - Dickerson, Jaime E Jr
AU  - Dickerson JE Jr
AD  - North Texas Eye Research Institute, University of North Texas Health Science 
      Center, Fort Worth, Texas; Sight Sciences, Inc, Menlo Park, California. 
      Electronic address: jdickerson@sightsciences.com.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20201009
PL  - United States
TA  - Ophthalmol Glaucoma
JT  - Ophthalmology. Glaucoma
JID - 101730510
SB  - IM
CIN - Ophthalmol Glaucoma. 2021 Mar-Apr;4(2):e6-e7. PMID: 33551370
CIN - Ophthalmol Glaucoma. 2021 Mar-Apr;4(2):e6. PMID: 33551371
MH  - *Glaucoma, Open-Angle/complications
MH  - Humans
MH  - Intraocular Pressure
MH  - Retrospective Studies
MH  - Tonometry, Ocular
MH  - *Trabeculectomy
OTO - NOTNLM
OT  - MIGS
OT  - Minimally invasive glaucoma surgery
OT  - OMNI
OT  - Schlemm's canal
OT  - ab interno
OT  - canaloplasty
OT  - open-angle glaucoma
OT  - trabeculotomy
OT  - viscodilation
EDAT- 2020/10/13 06:00
MHDA- 2021/10/29 06:00
CRDT- 2020/10/12 20:09
PHST- 2020/07/31 00:00 [received]
PHST- 2020/09/30 00:00 [revised]
PHST- 2020/10/01 00:00 [accepted]
PHST- 2020/10/13 06:00 [pubmed]
PHST- 2021/10/29 06:00 [medline]
PHST- 2020/10/12 20:09 [entrez]
AID - S2589-4196(20)30264-7 [pii]
AID - 10.1016/j.ogla.2020.10.001 [doi]
PST - ppublish
SO  - Ophthalmol Glaucoma. 2021 Mar-Apr;4(2):173-181. doi: 10.1016/j.ogla.2020.10.001. 
      Epub 2020 Oct 9.