Cheryl Guttman Krader, BS, Pharm

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Neither the need for unplanned postoperative visits for complications nor the incidence of visually disturbing cystoid macular edema (CME) was significantly reduced by adding a topical NSAID to postoperative topical steroid treatment, finds a recent study.

A retrospective population-based controlled study analyzing data from an unselected patient population undergoing phacoemulsification surgery found that neither the need for unplanned postoperative visits for complications nor the incidence of visually disturbing 

 was significantly reduced by adding a topical 

 to postoperative topical steroid treatment.

The research, however, did highlight increased susceptibility to postoperative CME in eyes with preexisting vitreoretinal conditions.

“Results of randomized controlled trials indicate that the occurrence of CME is reduced in eyes treated with an NSAID, either in combination with a steroid or alone,” said Jan GÃ¤rdin, MD, resident, 

Department of Ophthalmology, LinkÃ¶ping University

However, it is sometimes difficult to relate study results to what is perceived as clinical reality. In our investigator-initiated study including a large number of eyes from an unselected patient population, we were not able to demonstrate a clear benefit for the cohort that received combination therapy, Dr. GÃ¤rdin added.

Intracamerally injected mydriatic agents in cataract surgery: Good safety profile

“Although randomized controlled studies remain the gold standard for evaluating the efficacy of new treatments, adequately designed and conducted clinical studies such as our retrospective population-based trial are an important complement to clarify how medical and surgical treatments are used in an optimal fashion in unselected clinical populations," said 

, coinvestigator in the study and associate professor of ophthalmology, LinkÃ¶ping University. "The findings from such studies may have both medical and economic impact.”

The population-based controlled study analyzed data from two groups of consecutive patients operated on in the eye clinics of Vrinnevi Hospital, NorrkÃ¶ping, Sweden and LinkÃ¶ping University Hospital, LinkÃ¶ping, Sweden.

The two facilities are in the same county, publicly financed, and under the same regional clinical center, and they use the same electronic patient record system. However, they use different standard protocols for controlling postoperative inflammation, Dr. GÃ¤rdin explained.

Novel delivery system shows positive performance in phase II trial

At Vrinnevi Hospital, patients are treated for 3 weeks after surgery with a topical steroid and a topical NSAID, each given 3 times daily. Patients undergoing cataract surgery at the eye clinic of LinkÃ¶ping University Hospital are treated only with a tapering dose of a steroid for 3 weeks.

Using the electronic medical record system and beginning the search in January 2015, the investigators identified a total of 500 consecutive eyes from each hospital. The selected eyes were from patients aged 20 years and older.

Patients were excluded if they had posterior capsular rupture and/or zonular damage preventing in-the-bag IOL placement, deviation from the center’s standard protocol for topical anti-inflammatory treatment, or a pre-existing ocular malformation. Data were extracted on baseline characteristics and unplanned postoperative visits within 6 months after surgery.

The two study groups were balanced with respect to gender and right/left eye distribution. Each group had a predominance of females over males and included a majority of right eyes. Mean age was about 75 years and similar in the two study groups.

Mean logMAR BCDVA was also similar in the two groups preoperatively.

Managing ophthalmic surgery patients on antithrombotic drugs

A review of preoperative ocular comorbidities showed the percentage of eyes with pseudoexfoliation was higher in the group that received the steroid alone compared with those treated with combination therapy. The group receiving combination therapy had higher percentages of eyes with an epiretinal membrane (ERM) and with diabetic maculopathy or 

. The number of patients with diabetes and with 

Although a higher rate of unplanned postoperative visits was found for the group receiving combination treatment than among eyes treated only with a steroid, the difference was not statistically significant (16.6% versus 12.6%; 

 = 0.073). CME occurred in eight eyes (1.6%) in the combination treatment group and in six eyes (1.2%) treated with the steroid alone.

“The overall incidence of CME in our total cohort was 1.4%, but when patients with diabetes or an ERM were removed, the overall incidence of CME decreased to 0.8%,” Dr. GÃ¤rdin noted.

Clinically significant CME occurred in 2.9% of eyes in patients with diabetes mellitus and in 8.2% of eyes with an ERM.

“The incidence of clinically significant CME among patients in our study who had an ERM was 10-fold higher than in our patients without diabetes and no ERM, indicating patients with an ERM had a drastically increased risk,” Dr. GÃ¤rdin said.

Prevention of CME, infection in lens-based surgery: Evidence-based approaches


	Dr. GÃ¤rdin has no relevant financial interests to disclose.


	Dr. Johansson is a consultant to companies that market topical anti-inflammatory medications.

This article is based on a paper presented at the 2019 meeting of the American Society of Cataract and Refractive Surgery.

Articles

Large population-based study questions value of routine NSAID use after cataract surgery

This article was reviewed by Alice T. Epitropoulos, MD

Early real-world experience with the spherical aberration (SA) neutral monofocal toric 

(enVista MX60T, Bausch + Lomb) shows that it delivers predictable, stable correction of refractive astigmatism and provides an improved range of vision with excellent image quality, said Alice T. Epitropoulos, MD.

In a presentation at the ASCRS 2020 virtual annual meeting in May, Epitropoulos, clinical assistant clinical professor of ophthalmology at The Ohio State University Wexner Medical Center in Columbus, reported outcomes achieved in 40 consecutive eyes of 33 patients implanted with the SA neutral monofocal toric IOL. 

Aspheric, aberration-free IOL leverages technology for performance

Thirty-one eyes were targeted for distance (77.5%), and the refractive target in 9 eyes was for monovision (22.5%).

At 1 month postsurgery, MRSE was about 0.50 D target in 93% of eyes targeted for distance and 78% of those targeted for monovision. 

Results from functional testing showed that 77% of eyes had uncorrected visual acuity (UCVA) of 20/30 or better at distance and intermediate, and J3 or better at near.

“It is interesting that, despite having an essentially plano refraction postoperatively, patients who were targeted for distance had a surprising amount of intermediate and near vision with this monofocal lens. It is also worth noting that quite a few of the eyes in this series had either a history of refractive surgery or ocular comorbidities,” said Epitropoulos, who is in private practice at Ophthalmic Surgeons and Consultants of Ohio in Columbus.

“It seems that by preserving the cornea’s natural positive corneal SA because of its zero SA aspheric optic, the enVista toric IOL can give patients the best of both worlds in terms of good depth of focus and sharper quality of vision,” Epitropoulos said.


ASCRS 2020: Assessing aberration of monofocal toric IOL with enhanced optic recovery, alignment


Seven of the patients in the series underwent bilateral surgery. Epitropoulos performed all of the procedures. 

She noted that surgery was delayed for several patients while they were treated for existing ocular surface disease so that reliable topography and keratometry measurements could be obtained for surgical planning.

power calculations were performed using the Barrett Universal II (90%) or SRK-T (10%) formulas. Cylinder power (IOL plane) ranged from 1.25 to 5.00 D (mean 2.06) and was calculated based on the enVista toric calculator.

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At 1 month postoperatively, mean MRSE was reduced from –1.41 D preoperatively to –0.44 D, and average cylinder was reduced from 1.22 D preoperatively to 0.19 D. 

MRSE averaged –0.26 D (mean targeted MRSE -0.4D) among eyes targeted for distance and -1.03 D (mean targeted MRSE –1.43D) for the monovision eyes.

In the subgroup targeted for distance, distance UCVA was 20/30 or better in 100% of eyes and 20/20 or better in 80%. 

Intermediate UCVA was 20/25 or better in 87% of the 31 eyes that had been targeted for distance and in 100% of those targeted for monovision. 

Near UCVA was J3 or better in 87% of eyes targeted for distance and J2 or better in 100% of eyes targeted for monovision.

“Keep in mind that our average MRSE for monovision was only about 1 D. Our results reinforce that patients who choose monovision do not require as much anisometropia when using this lens,” Epitropoulos said.

Accurate data key for planning toric IOL surgery

Measurement of lens alignment showed that the toric IOL had excellent rotational stability. In all eyes, lens rotation between postop and both 1 day and 1 month was 5º or less.

“This result is similar to the outcome in the FDA clinical study where less than 6% of lenses rotated more than 5 degrees,” Epitropoulos said.



Options for correcting astigmatism during cataract surgery are important considering the prevalence of astigmatism and its effect on visual quality, Epitropoulos said.

“Approximately one-third of all patients who present for cataract surgery have at least 1 D of corneal astigmatism,” she said. “Left untreated, as little 0.5 D of astigmatism can affect the quality of uncorrected vision. Therefore, it is surprising that only 7% of all cataract procedures include implantation of a toric lens.”

In 2020, 3 monofocal toric IOLs were available in the United States. The enVista toric IOL, which was approved in 2018, is the newest of the 3 platforms.

“Its SA neutral aspheric optic is one feature that sets the enVista apart from the other monofocal toric IOLs,” Epitropoulos said. “In addition, the enVista toric IOL is the only toric IOL option on the market that is available in a toric power to treat astigmatism as low as 0.9 D at the corneal plane.” 


Epitropoulos is a consultant and speaker for Bausch + Lomb.

Monofocal toric lens delivers effective astigmatic correction and more, study results show


IOL offering treatment options for ophthalmologists 

This article was reviewed by Sandeep N. Shah, MD

A post hoc analysis of data from the Diabetic Retinopathy Clinical Research (DRCR) Network Protocol V provides new insight on outcomes of eyes with center-involve

 (CI-DME) and good best corrected visual acuity (BCVA) if treated with anti-VEGF therapy only upon worsening vision. 

The research also identified features associated with a need for intervention.

Association for Research in Vision and Ophthalmology 2020

Clinical trial outcomes for macular edema don’t translate to ‘real-world’ settings

“Protocol V randomized adults with type 1 or 2 diabetes who had CI-DME and Snellen equivalent BCVA of 20/25 or better to initial management with aflibercept [Eylea], focal/grid laser, or observation with aflibercept given in the laser and observation groups if VA decreased from baseline,” Shah said. “At 2 years, there was no difference in VA loss between the 3 study arms, and mean VA was 20/20 in all groups.”

Based on these results, Shah noted, many clinicians and patients might choose initial observation for eyes with CI-DME and good VA, withholding anti-VEGF treatment unless VA worsens.

Shah is the principal investigator for Protocol V (NCT01909791) at the Retina Vitreous Center in Oklahoma City, Oklahoma. 

According to Shah, the data show that some patients will do well if managed with observation and that using the DRCR Retina Network protocol-defined approach combining BCVA and 

)–measured central subfield thickness (CST) is an effective strategy for determining when to initiate anti-VEGF treatment.


VISTA subanalysis: Macular RNP and clinical outcomes

“Knowing risk factors that predispose to the need for anti-VEGF therapy helps in deciding follow-up intervals and patient education,” he said.

In Protocol V, a total of 236 eyes were selected randomly to initial management with observation. 

Per the protocol, patients were followed after 2 months. Treatment with aflibercept was initiated if VA worsened by 10 letters or more from baseline at any visit or if there was a loss of 5 to 9 letters at 2 consecutive visits.

The schedule for ongoing follow-up of eyes that did not have worsening of VA was determined based on findings of the OCT. If CST worsened, defined by an increase of at least 10% from the last visit or an increase to more than 400 µm, the follow-up interval was reduced to a minimum of 1 month. 

However, the maximum follow-up interval was extended to every 4 months for eyes that did not have worsening CST.

At least once during the 2 years of follow-up in the observation group, 19% of eyes experienced a BCVA loss of 10 or more letters and 39% experienced a 5- to 9-letter. 


ASRS 2020: Protocol T Extension Study shows long-term visual declines in DME eyes


At the next follow-up, however, just 32% of eyes had a sustained VA loss and began treatment with aflibercept, whereas 46% never went on to need aflibercept during the 2 years of the trial.

“These data show how important the role of repeatability of VA change is in an overall treatment regimen,” Shah said.

At the end of the 2-year follow-up, 66% of eyes did not require anti-VEGF treatment with aflibercept and 31% of those eyes had spontaneous resolution of

Within the subgroup of eyes that received anti-VEGF treatment per study criteria, VA was still good at 2 years (median, 20/25) and 70% did not lose more than 1 line of VA.

The analysis of factors associated with receipt of aflibercept showed greater baseline CST, having advanced diabetic retinopathy, and need for treatment of DME in the fellow eye increased the likelihood of intervention.

Eyes with baseline CST of at least 300 µm were approximately 2-fold more likely to go on to anti-VEGF treatment than eyes with less macular thickening.


New Protocol V findings offer guidance for managing DME

The impact of diabetic retinopathy severity was analyzed with eyes classified using the Early Treatment for Diabetic Retinopathy Study (ETDRS) grading system. 

It found that eyes with a Diabetic Retinopathy Severity Scale (DRSS) level of 47 or higher (moderately severe nonproliferative diabetic retinopathy [NDPR] and above) were 2.22 times more likely than eyes with a DRSS level of 43 or lower (moderate NPDR and below) to need aflibercept treatment.

A need for DME treatment in the fellow eye within 4 months of randomization increased the likelihood that a patient would receive aflibercept in the study eye by 2.55-fold.

“Even in these 3 higher-risk groups, only about 50% of the eyes received anti-VEGF treatment,” said Adam R. Glassman, MS, lead author of the 

 paper and director of the DRCR.net Coordinating Center of the Jaeb Center for Health Research in Tampa, Florida. “Therefore, although clinicians and patients should understand treatment expectations when they are in the higher-risk groups, many of these eyes still will not need treatment.”

Evaluating the change in VA, CMT after early switch of anti-VEGF drugs


According to Shah, the report’s limitations include the post hoc nature of the analysis and that it did not evaluate the laser group, which required fewer injections than the aflibercept group. 

In addition, some of the associations identified may have been due to chance, considering that multiple characteristics were evaluated. 

Finally, the treatment decisions were guided by VA measurements obtained with the E-ETDRS testing protocol refraction, which may differ from the approach used in clinical settings. 


Dr Shah has no relevant financial interests to disclose.


Glassman has no relevant financial interests to disclose.

1. Randleman JB, Woodward M, Lynn MJ, Stulting RD. Risk assessment for ectasia after corneal refractive surgery. Ophthalmology. 2008 Jan;115(1):37-50.

2. Ambrósio R Jr, Wilson SE. Complications of laser in situ keratomileusis: etiology, prevention, and treatment. J Refract Surg. 2001 May-Jun;17(3):350-379.

3. Godfrey KJ, Korn BS, Kikkawa DO. Blepharitis following ocular surgery: identifying risk factors. Curr Opin Ophthalmol. 2016 Jan;27(1):311-315.

4. Lopes BT, Ramos IC, Salomão MQ, Guerra FP, Schallhorn SC, Schallhorn JM, Vinciguerra R, Vinciguerra P, Price Jr FW, Price MO, Reinstein DZ, Archer TM, Belin MW, Machado AP, Ambrósio R Jr. Am J Ophthalmol 2018 Nov;195:223-232

Study results give ophthalmologists a plan for treating patients with good vision. 


Researchers: Protocol V findings offer physicians guidance for managing DME

Chance of getting, dying from non-ocular malignancies differs between men, women

The 10-year survival rate for patients with hereditary retinoblastoma is excellent, but these individuals are at increased risk for developing secondary cancers and have elevated mortality compared to age-matched individuals in the general population.
	
	According to analyses of data for retinoblastoma patients in the United States, there are gender-related differences in both the incidence of the different types of second non-ocular malignancies and cause-specific mortality, said Ruth Kleinerman, PhD.
	
	

Retinoblastoma screening rules set foundation for care


	
	“Based on this information, evidence-based guidelines for longterm surveillance and follow-up of retinoblastoma survivors should take gender into account,” said Dr. Kleinerman, deputy branch chief, Radiation Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD. “International pooling of second cancer data for retinoblastoma survivors will increase the number of cases of second cancers and provide statistical power to further investigate gender disparity in risk with greater precision.”
	
	Information on the incidence of second cancers in retinoblastoma survivors and rates of mortality related to the subsequent cancers is available from the National Cancer Institute Long-term Follow-up Study of Retinoblastoma Survivors.
	
	It includes data on 1,129 patients with hereditary retinoblastoma diagnosed between 1914 through 2006, of whom approximately 50% were still alive in 2016.
	
	Dr. Kleinerman said that the most common second cancers in the hereditary retinoblastoma survivors are bone cancer, soft tissue sarcoma, and melanoma. Analyses of cause-specific mortality compare the rates of death among retinoblastoma survivors with those reported for the U.S. population.
	
	The data show that female retinoblastoma survivors have a higher risk of dying of bone cancer, melanoma, and brain tumors and a slightly higher risk of dying of nasal cavity cancers compared with females in the general population.
	
	Rates of death due to lung, bladder, and colon cancer among female retinoblastoma survivors also appear to be higher than females in the general population. Male retinoblastoma survivors are at higher risk of dying of pancreatic cancer than males in the general population.
	
	

Retinoblastoma survival rates high; secondary cancer a risk


	Genetic susceptibility, treatment, and other factors might contribute to the increased risk of second cancers in patients with hereditary retinoblastoma.
	
	Hereditary retinoblastoma is caused by germline mutations in

, and the location of the mutation or the type of the mutation may be involved in the risk of some secondary cancers, including lung, bladder, and brain tumors. In addition, the patients may be carrying mutations in other related pathways.
	
	The RB1 gene is the spark for the creation of a protein called pRB, which acts as a tumor suppressor, meaning that it regulats cell growth and keeps cells from dividing to fast or in an uncontrolled way. The 

gene provides instructions for making a protein called pRB.
	
	This protein acts as a tumor suppressor, which means that it regulates cell growth and keeps cells from dividing too fast or in an uncontrolled way.
	
	“For example, 

 is in the same cell cycle control pathway as 

, which is a susceptibility gene for familial melanoma and pancreatic cancer,” Dr. Kleinerman said. Host characteristics, such as age and sex, as well as lifestyle and environmental factors, such as smoking history and sun exposure, may also play a role.
	
	Host characteristics, such as age and sex, as well as lifestyle and environmental factors, such as smoking history and sun exposure, may also play a role.
	
	


	This article is based on a presentation given by Dr. Kleinerman at the Ocular Oncology/Pathology Subspecialty Day meeting. The mortality data were subsequently published in the Journal of the National Cancer Institute (Kleinerman RA, et al. Patterns of causespecifi c mortality among 2053 survivors of retinoblastoma, 1914-2016. 

t. 2019 Jan 30. Doi: 10.1093/jnci/djy227 [Epub ahead of print]).
	

Dr. Kleinerman has no relevant financial interests to disclose.

Cheryl Guttman Krader, BS, Pharm

Articles

IOL offering treatment options for ophthalmologists

Researchers: Protocol V findings offer physicians guidance for managing DME

Research eyes risk of second cancers occurring in retinoblastoma patients

Large population-based study questions value of routine NSAID use after cataract surgery