Review of Ophthalmology Online

FROM THE EDITORS OF REVIEW OF OPHTHALMOLOGY:







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Volume 18, Number 32
Monday, August 6, 2018
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AUGUST IS CHILDREN’S EYE HEALTH/SAFETY MONTH



In this issue: (click heading to view article)
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######### Safety & Efficacy of Repeat Penetrating Keratoplasty
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######### OCT, FA & Diagnosis of CNV in AMD
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######### Conjunctival MUC5AC+ Goblet Cell Index: Relationship with Corneal Nerves & Dry Eye
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######### Panretinal Photocoagulation vs. Intravitreous Ranibizumab for PDR
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  Briefly

 

Safety & Efficacy of Repeat Penetrating Keratoplasty

Researchers investigated the safety and efficacy of repeat penetrating keratoplasty for treatment of a failed PK graft, as part of a retrospective, consecutive, clinical case series.

They retrospectively reviewed 96 cases that underwent repeat PK with more than three years postoperative follow-up at Baptist Eye Institute, Kyoto, Japan, between April 1998 and September 2013. They assessed surgical outcomes including donor graft survival rate, best spectacle-corrected visual acuity, endothelial cell density and complications.

After repeat PK, the donor graft survival rate was:
• 91 percent after one year;
• 5 percent after three years; and
• 64 percent after five years.
The mean endothelial cell density in surviving grafts was:
• 1,778 after one year;
• 1,207 after three years; and
• 989 cells/mm2 after five years.

The following BSCVA was achieved postoperatively in the the following percentage of cases:
• 71 percent over 20/200 and 27 percent over 20/40 at one year;
• 59 percent over 20/200 and 31 percent over 20/40 at three years; and
• 53 percent over 20/200 and 29 percent over 20/40 at five years.

The most common complication for repeat PK was the need for additional glaucoma surgery [n=11 individuals (11.5 percent)]. Cox proportional hazard regression analyses revealed that previous glaucoma surgery (HR=6.7; CI, 2.1 to 21.2), and rejection episodes (HR=5.6; CI, 1.8 to 18) were high risk factors for graft failure in repeat PK.

Researchers found that repeat PK provided relatively safe and effective moderately long-term surgical outcomes.

SOURCE: Kitazawa K, Wakimasu K, Kayukawa K, et al.
Moderately long-term safety and efficacy of repeat penetrating keratoplasty. Cornea 2018; Jul 26. [Epub ahead of print].





OCT, FA & Diagnosis of CNV in AMD

Scientists determined the sensitivity and specificity of different retinal imaging combinations to diagnose choroidal neovascularization in age-related macular degeneration.

Individuals age 50 or older referred for suspicious recent-onset CNV related to AMD were prospectively included for six months. Data recorded included color fundus photographs, spectral-domain optical coherence tomography and fluorescein angiography images. Five retina specialists randomly interpreted SD-OCT combined with CFP and FA combined with CFP. The reference diagnosis of CNV was based on the agreement of two readers’ interpretation of SD-OCT + FA + CFP combination. A total of 148 (148 eyes) were included. The researchers’ results included:

• For CNV diagnosis, the sensitivity of SD-OCT + CFP and FA + CFP was 90.9 percent.
• Type 2 CNV was diagnosed in 98 percent to 100 percent of cases with SD-OCT + CFP or FA + CFP.
• Type 1 CNV was diagnosed in 82.9 percent of cases with SD-OCT + CFP and 81.6 percent with FA + CFP.

Scientists wrote that SD-OCT combined with CFP had sensitivity and specificity similar to those of FA combined with CFP when used as a first diagnostic test for CNV in AMD. They added that the results pointed to the increasingly important role of SD-OCT as a first-line test in diagnosing CNV.

SOURCE: Gualino V, Tadayoni R, Cohen SY, et al. Optical coherence tomography, fluorescein angiography, and diagnosis of choroidal neovascularization in age-related macular degeneration. Retina 2018; Jul 24. [Epub ahead of print].



Conjunctival MUC5AC+ Goblet Cell Index: Relationship with Corneal Nerves & Dry Eye

Researchers evaluated the relative proportion of conjunctival MUC5AC+ and MUC5AC- goblet cells in a post-LASIK population and their association with dry-eye indicators and corneal nerve morphology using a MUC5AC+ Goblet Cell Index.

After recruiting 20 subjects who underwent LASIK>12 months previously and 20 age-matched controls, they examined dry-eye symptoms, tear breakup time, osmolarity, meniscus area and corneal nerve morphology. And they collected conjunctival impression cytology samples from inferior-temporal bulbar conjunctiva using Millicell inserts. Researchers determined total goblet cell density from positive cytokeratin-7 immunolabeling, and MUC5AC+ goblet cell density from CK7± and MUC5AC± immunolabeled cells. Researchers defined the ratio of MUC5AC+ to total density as the MUC5AC+ Goblet Cell Index. They examined differences in variables between groups, and associations between goblet cell variables and clinical assessments.

Researchers found no significant differences in total and MUC5AC+ goblet cell densities and tear film parameters between the groups, although greater ocular discomfort was reported in the post-LASIK group (p=0.02). A higher MUC5AC+ Index was associated with worse/greater dry-eye symptoms (ρ=0.55, p=0.01) and higher nerve tortuosity (ρ=0.57, p=0.01) in the post-LASIK group; lower nerve density and thickness was found in controls (ρ>-0.45, p<0.05), but not associated with tear film parameters.

Researchers determined that the MUC5AC+ Goblet Cell Index provided an indicator of mucin secretion for assessing the goblet cell function in dry eye. In post-LASIK participants, they found an increased MUC5AC+ Index associated with worse dry-eye symptoms and adverse changes in corneal nerve morphology.

SOURCE: Chao C, Golebiowski B, Stapleton F, et al. Conjunctival MUC5AC+ goblet cell index: Relationship with corneal nerves and dry eye. Graefes Arch Clin Exp Ophthalmol 2018; July 24. [Epub ahead of print].




Panretinal Photocoagulation vs. Intravitreous Ranibizumab for PDR

Investigators evaluated the efficacy and safety of 0.5-mg intravitreous ranibizumab vs. panretinal photocoagulation over five years for proliferative diabetic retinopathy. They evaluated 394 study eyes in the Diabetic Retinopathy Clinical Research Network multicenter randomized clinical trial with PDR, enrolled February through December 2012.

Eyes were randomly assigned to receive intravitreous ranibizumab (n=191) or PRP (n=203). The frequency of ranibizumab was based on a protocol-specified retreatment algorithm. Diabetic macular edema could be managed with ranibizumab in either group. The main outcome was mean change in visual acuity (intention-to-treat analysis). Secondary outcomes included peripheral visual field loss, development of vision-impairing DME and ocular and systemic safety.

The five-year visit was completed by 184 of 277 participants (66 percent excluding deaths). Of 305 enrolled participants, the mean (SD) age was 52 (12) years; 135 (44 percent) were women and 160 (52 percent) were white.

For the ranibizumab and PRP groups, respectively:
• the mean (SD) number of injections over five years was 19.2 (10.9) and 5.4 (7.9);
• the mean (SD) change in VA letter score was 3.1 (14.3) and three (10.5) letters (adjusted difference, 0.6; CI, -2.3 to 3.5; p=0.68);
• the mean VA was 20/25 (approximate Snellen equivalent) in both groups at five years; and
• the mean (SD) change in cumulative VF total point score was -330 (645) (n=41) vs. -527 (635) dB (n=38) groups (adjusted difference, 208 dB; CI, 9 to 408);
• vision-impairing DME developed in 27 vs. 53 eyes (cumulative probabilities: 22 percent vs. 38 percent; HR, 0.4; CI, 0.3 to 0.7); and
• no statistically significant differences were identified between groups in major systemic adverse event rates.

Investigators wrote that, although loss to follow-up was relatively high, VA in most study eyes that completed follow-up was very good at five years and similar in both groups. They added that severe vision loss or serious PDR complications were uncommon with PRP or ranibizumab; however, the ranibizumab group had lower rates of developing vision-impairing DME and less VF loss. Lastly, they wrote that the findings supported anti-vascular endothelial growth factor therapy or PRP as viable treatments for PDR. Investigators suggested that clinicians should consider patient-specific factors—including anticipated visit compliance, cost and frequency of visits—when choosing treatment for individuals with PDR.

SOURCE: Gross JG, Glassman AR, Liu D, et al. Five-year outcomes of panretinal photocoagulation vs. intravitreous ranibizumab for proliferative diabetic retinopathy: A randomized clinical trial. JAMA Ophthalmol 2018; Jul 24. [Epub ahead of print].





  • Imprimis Announces Multicenter Trial for Dropless TriMoxi in Canada
    Imprimis Pharmaceuticals announced Canadian partner Advanced Dosage Forms will begin enrolling patients at McGill University Health Centre for a clinical trial of Imprimis' leading Dropless (triamcinolone acetonide-moxifloxacin) formulation after a No Objection Letter was issued by Health Canada on January 4, and analytical tests required by Health Canada were completed July 11. The prospective, randomized, controlled crossover study of 200 bilateral cataract surgery patients will measure the outcomes of TriMoxi in one surgical eye vs. traditional eye drop therapy in the same patient for the other surgical eye. Read more.



  • Glaukos CEO Joins Avedro Board
    Avedro announced that Thomas W. Burns, president / chief executive officer of, and a board member at, Glaukos Corporation, was elected to its board of directors. In his 16 years at Glaukos, Burns has led the company from a small startup to an initial public offering in June 2015 and beyond. Over his career, he has raised nearly $400 million in private offerings and in the public markets. Burns previously led Eyetech Pharmaceuticals (acquired by OSI Pharmaceuticals) as president and chief operating officer. Read more.



  • RadianceTx Raises $1 Million Tranche to Develop Novel Glaucoma Therapy
    RadianceTx announced a $1 million first tranche closing of a targeted $7 million round of financing. The investment will be used to fund development of the company’s Beta Ophthalmic System for delivery of beta irradiation therapy to improve glaucoma surgery outcomes. A recent study reported that beta irradiation therapy patients were five-and-a-half times more likely to experience lower intraocular pressures at the end of one year than patients treated with the current standard of care. The system, designed to topically apply beta therapy to trabeculectomy or minimally-invasive glaucoma surgery drainage device implantation sites, requires only 25 seconds for beta therapy application and is intended to minimize stray dosing to non-target tissues and eliminate medical staff exposure to hazardous chemotherapy drugs, the company says. Read more.


  • Rhopressa Nominated as Prix Galien Best Pharmaceutical Product
    Among the Galien Foundation’s 2018 Annual Prix Galien USA Award nominees, Aerie’s Rhopressa was the only ophthalmic therapy nominated in the Best Pharmaceutical Product category. Prix Galien awards recognize outstanding biomedical and medical technology product achievement that improve the human condition. To qualify, each candidate must be U.S. FDA approved for marketing within the last five years and demonstrate “tremendous potential” to impact human health. Read more.



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