Exudation in Patients With Neovascular Age-Related Macular Degeneration Treated With the Port Delivery System or Monthly Injections.

PURPOSE: To evaluate for the presence, severity, and type of exudation at each study visit for a subgroup of patients with neovascular age-related macular degeneration from the Archway and Portal trials. DESIGN: Retrospective analysis of prospectively obtained data. METHODS: Spectral-domain optical coherence tomography scans from each study visit of 44 patients from the Port Delivery System (PDS) arm and 32 patients from the monthly injection arm of Archway were evaluated, and composites of horizontal scans through the fovea were created. Each composite was graded for the presence, type, and severity of exudation and impact on best-corrected visual acuity. RESULTS: After PDS implantation, 20 of 44 eyes (45%) never showed any exudation in the fovea, 2 (5%) never showed exudation in the fovea but had several missed visits, whereas 15 (34%), 3 (7%), and 4 (9%) showed mild, moderate, or severe exudation at 1 or more study visits, respectively. When exudation was present, it was most commonly subretinal fluid (50%). Of 32 patients randomized to monthly injections, 15 (47%) had no exudation in the fovea during monthly injections or after PDS implantation. Fluctuation of exudation in the fovea over time was seen in some patients after PDS implantation or during monthly injections with little or no identifiable impact on best-corrected visual acuity. In the 7 eyes with moderate or severe exudation in the fovea after PDS implantation, final vision was good in 5 (20/25 in 3, 20/40 in 1, and 20/50 in 1) and 2 had reduced vision from submacular hemorrhage. CONCLUSIONS: The PDS provides excellent control of exudation in the fovea in patients with neovascular age-related macular degeneration, and when exudation occurs, it often resolves without a negative impact on vision.

Conjunctiva and Tenon's Capsule Handling in the Port Delivery System with Ranibizumab Implant Insertion Procedure: Surgical Pearls.

OBJECTIVES: To describe conjunctiva and Tenon's capsule handling during the Port Delivery System with ranibizumab (PDS) implant insertion procedure including up-front assessments, planning, and instrumentation, with emphasis placed on the peritomy, scleral dissection, and closure steps. METHODS: Surgical pearls based on experience accumulated in the PDS clinical trial program in patients with retinal diseases. RESULTS: Preoperative preparation, specific instruments, and meticulous techniques are key to optimizing surgical outcomes. Before surgery, assessment of factors that affect conjunctival integrity and an in-office conjunctiva examination are conducted. Gentle, purposeful conjunctiva and Tenon's capsule handling with nontoothed forceps and suturing with a BV needle are recommended to prevent tissue damage. The peritomy is 6 mm by 6 mm, centered around the planned implant location in the superotemporal quadrant. A complete sub-Tenon's capsule dissection is achieved using a wide, robust lateral and posterior dissection technique to free tissue from the sclera and minimize tension. The globe is stabilized during scleral cutdown by grasping the sclera with fine-toothed forceps away from the incision edge to prevent tissue delamination. When closing the peritomy, both the conjunctiva and Tenon's capsule are completely captured and sutured with scleral anchoring at the apex of the peritomy to help prevent conjunctival retraction and erosion. Mitigation and detection of adverse events is critical to successful surgical outcomes. CONCLUSIONS: The PDS implant insertion procedure is straightforward, but it requires planned preoperative preparation, specific instruments, and meticulous techniques. The surgical pearls described here offer insights for optimizing outcomes. [Ophthalmic Surg Lasers Imaging Retina. 2022;53:266-273.].

Refill-Exchange Procedure of the Port Delivery System With Ranibizumab: Overview and Clinical Trial Experience.

PURPOSE: To describe the Port Delivery System with ranibizumab refill-exchange procedure. METHODS: Procedure based on the clinical trial program in patients with retinal diseases. RESULTS: The refill-exchange procedure is performed under topical anesthesia and strict aseptic conditions. Supplemental task lighting and magnification are recommended throughout the procedure. Ranibizumab is aseptically transferred from the vial with the filter needle and air is removed from the syringe. The filter needle is then replaced with the refill needle; any remaining air is removed from the syringe and the plunger is advanced to the 0.1-mL mark. Targeting the implant septum center, the refill needle is inserted perpendicularly to the globe until the soft stop contacts the conjunctiva (perpendicular orientation and conjunctival contact are maintained throughout the procedure); a cotton-tipped applicator is recommended for globe stabilization. The entire syringe contents are slowly injected over 5-10 seconds while existing solution fills the fluid collection reservoir. Once completed, the needle is carefully withdrawn while maintaining perpendicularity. The procedure can be successfully performed in rare, specific cases, including subconjunctival thickening or fibrous capsule formation, fluid-filled bleb formation, and corneal patch grafts. CONCLUSION: The procedure is straightforward but distinct from intravitreal injections and requires adherence to standardized techniques. With appropriate preparation, the procedure can be performed in specific cases. [Ophthalmic Surg Lasers Imaging Retina. 2022;53:257-265.].

Intraoperative sclerotomy-related retinal breaks during 23-gauge pars plana vitrectomy.

PURPOSE: To study the incidence and characteristics of intraoperative sclerotomy-related retinal breaks encountered during 23-gauge pars plana vitrectomy. METHODS: A retrospective consecutive case series was assembled from the surgical logs and charts of patients who underwent 23-gauge pars plana vitrectomy. Demographic data and preoperative, intraoperative, and postoperative records were examined. RESULTS: A total 548 eyes met the inclusion criteria. Of them, 145 eyes underwent pars plana vitrectomy for repair of a rhegmatogenous retinal detachment (RRD) and 403 eyes for other indications. Sclerotomy-related retinal breaks were found in 8 of 548 (1.45%) eyes. No breaks were found in the 145 RRD eyes. In non-RRD cases, 8 of 403 (1.98%) eyes had sclerotomy-related breaks. All breaks were adjacent to the superior sclerotomies. The incidence of postoperative retinal detachment was 0% (0 of 403) in the non-RRD group. In eyes with breaks, the primary surgical indication was vitreomacular traction in six of eight eyes and epiretinal membrane in two of eight eyes. Posterior vitreous detachment was absent in six of eight eyes, and six of eight eyes were phakic. Eyes with vitreomacular traction had a significantly higher incidence of breaks (P < 0.0001). Eyes with a surgical indication other than RRD had a higher incidence of breaks, but this was not statistically significant when compared with eyes with RRD (P = 0.087). CONCLUSION: Pars plana vitrectomy (23-gauge) is associated with a low incidence of sclerotomy-related retinal breaks and postoperative retinal detachments. Eyes with breaks are more likely to be phakic and without a preoperative posterior vitreous detachment. The presence of vitreomacular traction may be a risk factor for the development of intraoperative sclerotomy-related breaks.

Temporal approach for small-gauge pars plana vitrectomy combined with anterior segment surgery.

PURPOSE: To describe our preliminary experience with temporal small-gauge pars plana vitrectomy (PPV) techniques used to treat anterior and posterior segment pathology. METHODS: A retrospective consecutive case review of patients who underwent temporal PPV was performed. Patients underwent combined temporal small-gauge PPV and anterior segment intervention. Pre- and postoperative visual acuity, intraocular pressure, surgical indications, intraoperative techniques, postoperative course, and a survey to determine how the change in position affected surgery were examined. RESULTS: Temporal PPV was performed on 23 eyes with various posterior segment indications and anterior segment pathologies including cataract, pupillary membrane, endophthalmitis, superior filtering blebs, and anterior vitreous membranes. In 20 eyes, 23-gauge instruments were used, and in 3 eyes, 25-gauge instruments were used. Mean postoperative follow-up duration was 7.6 ± 5.0 months (range, 3-22 months). Surgical objectives were achieved in all cases, and no complications occurred in any study eye. Preoperative logarithm of the minimum angle of resolution mean visual acuity was 1.89 ± 0.76 and improved significantly on postoperative Week 1 (1.45 ± 0.81, P = 0.0003), Month 1 (1.13 ± 0.86, P = 0.0001), and at final follow-up (0.88 ± 0.79, P = 0.0001). There was no significant difference in preoperative and postoperative intraocular pressures. Surgeon surveys indicated significant advantages with a temporal approach for each anterior segment indication, no significant differences in performing the basic surgical steps of PPV, and relative ease of adopting this technique. CONCLUSION: Performing PPV from the temporal position seems to be advantageous in cases combining posterior and anterior segment surgery such as cataract extraction, pupillary membrane dissection, preservation of superior conjunctival blebs, and trimanual vitrectomy.

Sutureless triplanar sclerotomy for 23-gauge vitrectomy.

OBJECTIVES: To describe and test the intraoperative integrity of triplanar sclerotomies. METHODS: A prospective consecutive case series of 180 sclerotomies in 60 eyes was studied. After conjunctival dissection, triplanar transscleral wounds were created with a 23-gauge trocar using a standardized technique. At the conclusion of surgery, an air-fluid exchange was performed, and cannulas were removed. Then, unsutured scleral wound integrity was tested for permeability to vitreous, gas, and fluid by application of a cellulose sponge, observation of gas escape, and examination by the Seidel method, respectively. Postoperative intraocular pressure was recorded. Laboratory studies with fresh human donor globes were conducted to evaluate the histologic characteristics of triplanar sclerotomies. RESULTS: Unsutured triplanar wounds were closed to vitreous, gas, and fluid in 169 of 180 sclerotomies (93.9%). Eleven sclerotomies were open and showed positive results using only 1 testing method each. In these cases, vitreous was detected in 1 wound, gas escaped from 8 wounds, and Seidel test results were positive in 2 wounds. Complex retinal detachment repairs had a higher rate of wounds requiring suture placement. One patient had transient postoperative day 1 hypotony. CONCLUSIONS: It is possible to achieve high rates of unsutured wound closure with triplanar transscleral sclerotomies. No single method of evaluating wound leakage appeared to be the most sensitive. More complex cases requiring longer surgical times, more instrument passes, and increased wound manipulation resulted in higher rates of wound leakage. Leakage can be subtle, and surgeons should use multiple methods to adequately assess sclerotomy closure.

Fluoroquinolone therapy in Mycobacterium chelonae keratitis after lamellar keratectomy.

PURPOSE: To characterize a rabbit model of Mycobacterium chelonae keratitis after lamellar keratectomy and assess the effectiveness of fluoroquinolone therapy. SETTING: University Laboratory, University of California, Irvine, California, USA. METHODS: Twenty-eight New Zealand white rabbits had unilateral lamellar keratectomy with placement of 2.5 x 10(5) colony-forming units of log-phase M chelonae under each flap. Eyes (7 per group) were randomized and treated with sterile balanced salt solution, gatifloxacin 0.3%, ciprofloxacin 0.3%, or levofloxacin 0.5% 4 times daily. Two masked observers examined all eyes on days 2, 5, and 7 and weekly for 4 weeks. Severity of disease and bacterial culture results were the main outcomes measured. The means and standard deviations were calculated, and differences between the groups were statistically analyzed. RESULTS: All eyes developed clinical disease. At the time the rabbits were killed, eyes treated with balanced salt solution, ciprofloxacin, levofloxacin, and gatifloxacin were culture positive in 6 (85.7%), 7 (100%), 6 (85.7%), and 3 (42.9%) of 7 eyes per group, respectively. Frequency of positive culture and the severity of clinical disease in gatifloxacin-treated eyes were significantly less (P < .05) than in the other groups combined. CONCLUSIONS: The rabbit model of M chelonae keratitis was successfully developed in our study. A fourth-generation quinolone (gatifloxacin) showed the best performance among the fluoroquinolones tested in our experimental approach. The fourth-generation fluoroquinolone, gatifloxacin, could be effectively used for the treatment of mycobacterial keratitis.

In vitro measurement of rabbit corneal epithelial thickness using ultrahigh resolution optical coherence tomography.

The objective of this study was to reproducibly measure corneal epithelial thickness centrally and at the limbus in the rabbit cornea using ultrahigh resolution optical coherence tomography (OCT). Twelve freshly enucleated New Zealand white rabbit eyes were kept in a moist chamber at 4 degrees C. An ultrahigh resolution OCT system with a spatial resolution of 1.3 microm was used to image the cornea and its component layers. The central and peripheral (limbal) regions of all the samples were scanned within 6 h of harvest in order to minimize the post-mortem degradation of the corneal epithelium. The thickness of the corneal epithelium was determined by measuring the pixel equivalents of the obtained image. Unpaired Student's t-test was used to evaluate differences. The epithelial thickness centrally was found to be 45.8 +/- 2.2 microm, and 37.6 +/- 1.4 microm at the limbus (P < 0.001). Rabbit corneal epithelium is thicker centrally than at the limbus when measured by ultrahigh resolution OCT. This technique will aid in delineating the pathophysiology of diseases of the anterior cornea.

A rat model of radiofrequency ablation of trigeminal innervation via a ventral approach with stereotaxic surgery.

Neurotrophic keratopathy (NK), a consequence of sensory denervation of the cornea, must be better understood in order to develop new approaches to therapy. The purpose of this study was to create a rat model for neurotrophic keratopathy by denervating the trigeminal nerve through a ventral approach with stereotaxic surgery. Stereotaxic coordinates were measured in 46 male Sprague Dawley rat cadavers for localization of V1. After further refining the coordinates in nine live animals, radiofrequency ablation was chosen as an effective method of disrupting the innervation to the cornea. Fifty-two live rats were treated with radiofrequency ablation to define the anatomical localization of the lesion by utilizing gross and histopathological studies. A gross lesion of the trigeminal nerve and/or ganglion was observed in 47 (90%) of the 52 animals. Histopathological studies revealed that all 52 animals had anatomical damage of the trigeminal innervation to the eye. Low mortality and little morbidity were observed in these animals. We have developed a rat model for neurotrophic keratopathy that is simple to produce, accurate in creating a lesion by utilizing stereotaxic techniques combined with radiofrequency ablation, and successful in decreasing morbidity and mortality.

Biomechanical characterization of human amniotic membrane preparations for ocular surface reconstruction.

PURPOSE: To investigate the tensile and elastic properties of both commercially available and experimental human amniotic membrane preparations. METHOD: Nine preparations of human amniotic membrane were studied. The four dry preparations were untreated (nonirradiated, n = 20), and gamma (n = 25), low-dose (AmbioDry, Okto Ophtho Inc., Costa Mesa, Calif., USA, n = 20) and high-dose (n = 20) electron beam sterilized. The same dry membranes were moistened with balanced salt solution (n = 20, 34, 20 and 20, respectively). The ninth group consisted of thawed medium-frozen amniotic membrane (AmnioGraft, Bio-Tissue Inc., Miami, Fla., USA, n = 20). The membranes were cut into thin strips, loaded on a gram range load sensor, and stretched incrementally to the point of rupture. The modulus of elasticity, displacement until rupture and maximum tolerated stress were recorded and compared. RESULTS: The dry preparations exhibited higher moduli of elasticity when compared with the moist samples, with the low-dose electron beam-irradiated samples having the greatest mean modulus of elasticity overall and maintaining a high modulus of elasticity as a moist sample (p < 0.05). Moist nonirradiated preparations and thawed medium-frozen preparations stretched the farthest before rupture and experienced the greatest mean stresses at the point of rupture. While 3 of 4 membranes had greater stretch when moistened as compared to their dry counterparts, there was no difference in the membrane stiffness between dry and moistened low-dose electron beam-irradiated samples (p > 0.8). CONCLUSIONS: Low-dose electron beam-irradiated amnion appeared to maintain desirable elastic characteristics in transition from a dry to rehydrated state and may thus provide an easy-to-manipulate transplant tissue for ocular surface reconstruction. Moist nonirradiated and thawed medium-frozen tissues, however, may provide surgical advantages as they required greater forces to rupture.