iOR Office-Based Surgery: Safety & Efficacy

Nearly a decade after the first ophthalmic office-based surgery (OBS) suite made its debut, a growing body of research demonstrates that OBS offers both surgeons and patients a multitude of benefits and safety that match, and in some cases exceed, that of hospital outpatient departments (HOPDs) and ambulatory surgery centers (ASCs).

Patient safety is paramount to the success of OBS. A common misconception is that OBS is performed in standard procedure rooms. In fact, office-based surgical suites are bona fide operating rooms that operate under the same safety and accreditation standards as ASCs and hospitals. They are regulated in all 50 states and operate under the physician’s license governed by the individual state board of medicine using either Class A (oral; e.g., Valium) or Class B (monitored IV) anesthesia.

Cataract surgery is not safe in the office given the age and comorbidities of cataract patients.
The intricate, delicate, and complicated surgical procedures performed by varying experienced eye surgeons remain a concern when performed outside of a full facility operating theater.
Sterility controls are inferior to a hospital operating room or a dedicated ambulatory surgical center (ASC) operating theater.
OBS does not require anesthesia to be administered and monitored by an anesthesiologist.
OBS staff are likely to have expertise in eye surgeries and patient care, but ASC staff may be better equipped to handle a broader range of surgical complications.

Published data shows that patients ages 65+ had overall occurrence rates similar to total cohort.
iOR Suites are full operating theaters specifically designed for the procedures performed in them, with the same facility layout and environment standards found in an ASC.
iOR Suites follow the same ophthalmic safety standards, protocols, sterility, and infection control as an ASC or HOPD.
Patients in iOR suites are monitored to the accreditation standards for either Class A or Class B anesthesia.
In iOR Suites, appointments to the medical staff are only extended to qualified and credentialed physicians and allied healthcare professionals who continuously meet the standards set for them by the governing body. The requirements ensure that staff is trained to respond to surgical complications.

In 2016, one of the largest U.S. studies to investigate the safety and effectiveness of OBS was conducted by Ianchulev, et al, at a Kaiser Permanente Colorado integrated healthcare center.¹ The researchers reviewed 13,507 patients (21,507 eyes) with a mean age of 72.6+/-9.6 years who underwent elective office-based cataract surgery between 2011 and 2014. It was concluded that office-based outcomes were consistently excellent, with a safety profile expected of minimally invasive cataract procedures performed in ASCs and HOPDs.

More recently, Kugler et al., evaluated the case records of 18,005 patients who underwent OBS for a visually significant cataract, refractive lens exchange (RLE), or phakic IOL implantation at 36 participating U.S. sites.² “Our study demonstrated that the safety profile of office-based lens surgery either matches or exceeds the literature-reported values of adverse events documented for modern cataract surgery,” says Lance J. Kugler, MD, director of Kugler Vision, Omaha, NE.

Third, iOR Partners collects data on cases performed in iOR surgical Suites® as part of their accreditation program. Occurrence data collected quarterly from surgeries performed in multiple centers using different surgical techniques, shows that safety outcomes match or exceed those of other outpatient settings.³

	iOR Data 57 centers 47,414 procedures	Kugler et al, 36 centers 18,005 cases	Kaiser Permanente 13,507 patients (21,501 eyes) age 72.6 +/- 9.6 years
Endophthalmitis	0.015%   (7)	.028%	0 reported cases
Unplanned Vitrectomy	0.198%   (94)	0.177%	unreported
Return to the OR	0.084%   (40)  (most for removal of residual cortex)	.067%	.70%  (second surgery performed within six months)
TASS or Significant Iritis	0.016%   (8)	.022%	1.53%
Corneal Edema	0.016%   (8)	.027%	.53%
Referred to Hospital	0.004%    (2) (nausea and unable to keep food and fluids down), (previously undiagnosed AFib)	.011%	.0002% (severe headache, near syncope, and patient fall)

Oral Sedation: A Safer Option for Cataract Surgery

Office-based procedures are just as safe as procedures performed in any other setting because the level of anesthesia is entirely appropriate to the level of care provided. In fact, a growing body of research shows that mild sedation is usually a better course of treatment for the patient.

Breathing response is less decreased

Lower medical risks (e.g., less over-sedation)

Less postoperative nausea/vomiting

Less undesired patient movement

Better patient cooperation

Safety & Efficacy

of Ophthalmic Office-Based Surgery

93,000+ SUCCESSFUL OUTCOMES ACCELERATE THE MOVEMENT TOWARD OFFICE-BASED SURGERY

OBS Safety Myths vs. Facts

Myths

Facts

Office-Based Surgery is the Embodiment of Safe and Effective Surgery

Office-Based Surgery Documented Outcomes

IOR PARTNERS PATIENT PROFILE

Average Age by Procedure Type

General Comorbidities (age 65+)

Cataract Patients Ocular Comorbidities

Oral Sedation: A Safer Option for Cataract Surgery