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Research

JAMA Ophthalmology | Brief Report

Reported Complications Following Laser Vitreolysis


Paul Hahn, MD, PhD; Eric W. Schneider, MD; Homayoun Tabandeh, MD; Robert W. Wong, MD;
Geoffrey G. Emerson, MD, PhD; for the American Society of Retina Specialists Research and Safety
in Therapeutics (ASRS ReST) Committee

IMPORTANCE Use of laser vitreolysis for symptomatic floaters has increased in recent years,
but prospective studies are not available and the complication profile is poorly understood.

OBJECTIVE To analyze cases of complications following laser vitreolysis as voluntarily


reported to the American Society of Retina Specialists Research and Safety in Therapeutics
(ASRS ReST) Committee, an independent task force formed to monitor device-related and
drug-related safety events.

DESIGN, SETTING, AND PARTICIPANTS A retrospective assessment was performed of all cases
of complications following laser vitreolysis that were voluntarily reported by practitioners
throughout the United States to the ASRS ReST Committee from the first report on
September 19, 2016, through March 16, 2017, the date of data analysis and manuscript
writing.

MAIN OUTCOMES AND MEASURES Complications reported to the ASRS ReST Committee
following laser vitreolysis were analyzed by type to gain an understanding of the spectrum of
potential complications.

RESULTS A total of 16 complications following laser vitreolysis were reported in 15 patients by


7 US vitreoretinal specialists during the study period. Complications included elevated
intraocular pressure leading to glaucoma; cataracts, including posterior capsule defects
requiring cataract surgery; retinal tear; retinal detachment; retinal hemorrhages; scotomas;
and an increased number of floaters.

CONCLUSIONS AND RELEVANCE This report presents a spectrum of complications reported to


the ASRS ReST Committee across 6 months. The rate of complications cannot be determined
because the denominator of total cases is unknown. Also, these findings cannot determine
whether there is a causal association between these complications and laser vitreolysis.
Prospective studies are warranted to better understand the efficacy of this procedure and the
frequency of attendant complications. Until then, practitioners should be aware of the profile
of potential complications to properly inform patients during the consent process. The ASRS
ReST Committee will continue to monitor device-related and drug-related adverse events and
encourages active surveillance and reporting by all physicians.
Author Affiliations: NJRetina,
Teaneck, New Jersey (Hahn);
Tennessee Retina, Nashville
(Schneider); Retina-Vitreous
Associates Medical Group,
Los Angeles, California (Tabandeh);
Austin Retina Associates, Austin,
Texas (Wong); Retina Center of
Minnesota, Minneapolis (Emerson).
Group Information: A complete list
of the members of the American
Society of Retina Specialists Research
and Safety in Therapeutics (ASRS
ReST) Committee appears at the end
of this article.
Corresponding Author: Geoffrey G.
Emerson, MD, PhD, Retina Center
of Minnesota, 710 E 24th St, #301,
JAMA Ophthalmol. doi:10.1001/jamaophthalmol.2017.2477 Minneapolis, MN 55403
Published online July 27, 2017. (geoffrey.g.emerson@gmail.com).

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Research Brief Report Reported Complications Following Laser Vitreolysis

N
d:YAG laser vitreolysis of symptomatic floaters is
not a newly described procedure,1-5 but anecdotal Key Points
reports suggest that the use of this procedure may
Question What complications were reported voluntarily to the
be increasing, perhaps owing in part to the marketing of American Society of Retina Specialists Research and Safety in
laser systems optimized for vitreolysis. To our knowledge, Therapeutics Committee during a 6-month period in 2016-2017
there are no peer-reviewed prospective trials evaluating this following laser vitreolysis for the treatment of symptomatic
approach, and its efficacy and complication profile are floaters?
poorly understood. Findings In this case series assessment of 15 patients,
The American Society of Retina Specialists (ASRS) Re- complications included glaucoma; cataracts, including posterior
search and Safety in Therapeutics (ReST) Committee serves as capsule defects requiring cataract surgery; retinal tear; retinal
an independent task force to objectively monitor device- detachment; retinal hemorrhages; scotomas; and an increased
related and drug-related adverse events. Fundamental to the number of floaters.
effectiveness of the ASRS ReST Committee is collection and Meaning Ophthalmologists, particularly those offering laser
prompt dissemination of information about adverse events that vitreolysis for symptomatic floaters, should be aware of the
are invariably time sensitive. potential complications associated with this procedure.
During a 6-month period in 2016-2017, the ASRS ReST Com-
mittee received reports of complications following laser vit-
reolysis. In the absence of prospective data, these voluntarily The remaining case did not include details beyond the pres-
submitted, unsolicited reports may help define a spectrum of ence of cataract. Of the 5 cases of prolonged elevation of in-
associated complications. traocular pressure, 3 resulted in secondary glaucoma, and tra-
beculectomy was required in 2 of these cases. Retinal
detachment was reported in 2 cases and a retinal tear in 1 case.
Laser injury–related transient posterior pole retinal hemor-
Methods rhages were reported in 2 cases (Figure); in one of these cases,
The ASRS ReST Committee collected voluntary, unsolicited re- the patient remained asymptomatic, while in the other, a tran-
ports of all device-related and drug-related adverse events that sient scotoma was seen that lasted a few weeks and corre-
were submitted from September 19, 2016, through March 16, sponded to the area of subretinal hemorrhage with nearby reti-
2017, through a ReST reporting form on the ASRS website or nal whitening. An increased number of symptomatic floaters
via personal communication with committee members. Ow- were reported in 1 patient following laser vitreolysis. In 14 pa-
ing to the sensitive nature of procedural complications, only tients, a single complication was reported, whereas in 1 pa-
details reported voluntarily without solicitation were ana- tient, both glaucoma and a retinal tear were reported.
lyzed. This study was deemed exempt from institutional re-
view board oversight based on personal communication with
the Human Research Protection Program at Allina Health. All
patient information was deidentified.
Discussion
On behalf of the ASRS ReST Committee, we present a spec-
trum of complications in 15 patients following laser vitreoly-
sis. This analysis was based on voluntary reports submitted
Results during a 6-month periond to the ASRS ReST Committee. These
The ASRS ReST Committee received reports of complications 15 cases represent, to our knowledge, the largest collection of
in 15 patients following laser vitreolysis. These reports were complications reported to date and include complications of
submitted by 7 clinicians (all retina specialists). The median elevated intraocular pressure leading to glaucoma; cataracts,
number of reports per clinician was 1 (range, 1-6). Most pa- including posterior capsule defects requiring cataract sur-
tients (14 of 15) were treated with laser vitreolysis elsewhere gery; retinal tear; retinal detachment; retinal hemorrhages; sco-
by a comprehensive ophthalmologist; in 1 case, the reporting tomas; and an increased number of floaters.
retina specialist performed the laser vitreolysis. Geographic lo- Peer-reviewed reports regarding laser vitreolysis are lim-
cation of the adverse events was spread across the United ited. A few small case series and individual case reports have
States, with 6 reports from the Northeast, 6 from the West, 2 described complications, including transient elevation of in-
from the Southeast, and 1 from the Southwest. traocular pressure,6 refractory glaucoma requiring surgery,7
Following laser vitreolysis, 16 complications were re- and acute cataract formation or posterior lens capsule injury8-10
ported among the 15 patients. The most frequently reported requiring surgery, with implantation of an intraocular lens into
complications were focal cataracts (5 cases) and prolonged el- the sulcus.11,12 Cases of retinal detachment,8,9 uveitis,6 reti-
evation of the intraocular pressure (5 cases). Three of the fo- nal hemorrhage,8,10 and an absolute scotoma hypothesized to
cal cataracts were within the visual axis, 2 of which had asso- be secondary to a detached fragment of neurosensory retina13
ciated posterior capsule rupture. Subsequent cataract have also been described. In the largest peer-reviewed study
extraction was performed in 2 of these cases, while further de- to date, a retrospective review of 39 eyes treated with laser vit-
tails were not available for the third. A fourth cataract was re- reolysis did not report any postoperative complications, but
ported in the posterior cortex peripherally and was observed. 7.7% of treated eyes experienced worsening symptoms.14

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Reported Complications Following Laser Vitreolysis Brief Report Research

Figure. Transient Hemorrhage and Scotoma Following Laser Vitreolysis

A Three days after laser vitreolysis

B Retinal whitening and hemorrhage C One month after laser vitreolysis

A, Fundus photograph of a patient 3


days after laser vitreolysis.
B, Enlargement of the boxed area in
part A demonstrating retinal
whitening with associated retinal
hemorrhage and possible microhole
(white arrowhead) and another area
of subretinal hemorrhage (black
arrowhead). This patient had a
superotemporal scotoma
corresponding to the location of this
pathologic finding. C, One month
later, these findings and scotoma
have nearly resolved spontaneously.

The spectrum of complications submitted to the ASRS ReST plications, although robust, is likely underreported and not com-
Committee is consistent with these previous reports and prehensive, and there is no way to currently evaluate the num-
indicates that these complications remain relevant to laser ber of laser vitreolysis procedures performed. This type of
vitreolysis as currently performed. analysis cannot estimate complication rates or their relative fre-
quencies, which would be best determined in prospective, con-
Limitations trolled studies. Nearly all reported complications were submit-
There are inherent limitations to this retrospective analysis of ted by physicians other than the treating clinician, suggesting
voluntarily submitted reports. This collection of reported com- underreporting due to reluctance to report complications in

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Research Brief Report Reported Complications Following Laser Vitreolysis

one’s own patients. Alternatively, laser vitreolysis may be per- ment details, outcomes including floater dissolution and pa-
formed most commonly by general ophthalmologists, while re- tient satisfaction, and other clinical details are important but
porting to ASRS is most commonly done by retina specialists. not well captured from analysis of voluntary reports. The goals
Furthermore, the submitted reports were based on the re- of this pilot assessment were to gauge the spectrum of com-
porting physician’s assessment without additional valida- plications in order to promptly communicate these findings
tion. This analysis cannot definitively identify a causal asso- to the ophthalmology community.
ciation between laser vitreolysis and these complications. In
addition, these reports did not include details about tech-
niques, equipment, or experience level of the treating clini-
cians, which is particularly important for procedures for which
Conclusions
formal training is not common. However, the geographic dis- Because laser vitreolysis procedures appear to be increasingly
tribution of the 15 submitted cases broadly across the United performed, it is important for clinicians to be fully aware of its
States suggests that these complications are not attributable risk vs benefit profile. Success rates in the peer-reviewed lit-
to a single clinician, device, experience level, or technique. erature have been reported only in small retrospective series
Because of the sensitive nature of procedural complica- ranging from 0% to 100%.15 Rigorous prospective studies will
tions, particularly those generally not performed by the re- be critical to better understand the efficacy of this procedure
porting retina specialist and compounded by the “off-label” and the frequency, prognosis, and mechanism of associated
nature of this procedure, the ASRS ReST Committee chose not complications. The ASRS ReST Committee will continue to
to solicit further information from reporting clinicians at the monitor and communicate ongoing reports of all device-
time of this pilot assessment. Visual acuity changes, manage- related and drug-related adverse events.

ARTICLE INFORMATION Consultants, Sacramento, California; Eric W. neodymium-yttrium-aluminum-garnet laser lysis of


Accepted for Publication: June 6, 2017. Schneider, MD, Tennessee Retina, Nashville; vitreous floaters. Am J Ophthalmol. 2015;159(1):
Michael A. Singer, MD, Medical Center 138-143.
Published Online: July 27, 2017. Ophthalmology Associates, San Antonio, Texas;
doi:10.1001/jamaophthalmol.2017.2477 8. Little HL, Jack RL. Q-switched neodymium: YAG
Homayoun Tabandeh, MD, Retina-Vitreous laser surgery of the vitreous. Graefes Arch Clin Exp
Author Contributions: Dr Emerson had full access Associates Medical Group, Los Angeles, California; Ophthalmol. 1986;224(3):240-246.
to all the data in the study and takes responsibility Andre Witkin, MD, Tufts Medical Center, Boston,
for the integrity of the data and the accuracy of the Massachusetts; and Robert W. Wong, MD, Austin 9. Tassignon MJ, Kreissig I, Stempels N, Brihaye M.
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Tabandeh, Emerson. Committee thanks the reporting practitioners who
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