Long-Term Astigmatism after Intraocular Pressure Sensor Implantation and Nonpenetrating Glaucoma Surgery - EYEMATE-SC Trial.

PURPOSE: To investigate the long-term astigmatism after combined non-penetrating glaucoma surgery (NPGS) and implantation of the first miniaturized suprachoroidal intraocular pressure (IOP) sensor EYEMATE-SC. SETTING: The study was conducted in five medical centers in two different countries. DESIGN: Retrospective multicenter clinical study. METHODS: Astigmatism of patients instrumented with the EYEMATE-SC IOP sensor was assessed over a follow-up period of three years. Refraction and corrected distance visual acuity (CDVA) were obtained preoperatively, after 6 months, 1, 2, and 3 years. A canaloplasty-operated patient cohort served as control. Astigmatism was evaluated using 3-dimensional power vector analysis involving the spherical equivalent M, and the Jackson crossed cylinder projections J0 and J45. Exclusion criteria included neovascular and angle-closure glaucoma, myopia, axial length outside 22 to 26 mm, other ocular diseases, prior glaucoma surgery, other ocular surgery within 6 months (cataract surgery within 3 months) prior to NPGS, serious generalized conditions, and other active medical head/neck implants. RESULTS: Multivariate analysis indicated no changes in astigmatism along the observation period in both the EYEMATE-SC (n = 24) and the canaloplasty (n = 24) group (P > 0.05 or nonsignificant after Bonferroni correction). Astigmatism was unchanged between the EYEMATE-SC and the canaloplasty group at all time points (P > 0.05). CDVA didn't change along the observation period of three years in each of both groups (P > 0.05). CONCLUSIONS: Despite its suprachoroidal localization, the present study indicates that the miniaturized EYEMATE-SC IOP sensor doesn't negatively affect the long-term astigmatism after combined implantation with NPGS.

Two-Year Performance and Safety Results of the MINIject Supraciliary Implant in Patients With Primary Open-Angle Glaucoma: Meta-Analysis of the STAR-I, II, III Trials.

PURPOSE: To evaluate the performance and safety of minimally invasive glaucoma surgery with a supraciliary drainage device (MINIject; iSTAR Medical, Wavre, Belgium) in primary open-angle glaucoma (POAG) as a stand-alone procedure. DESIGN: Meta-analysis. METHODS: At 11 sites in Colombia, France, Germany, India, Panama, and Spain, 82 patients were treated in 3 prospective, multicenter, interventional, nonrandomized trials (STAR-I, II, III). Data were pooled in a meta-analysis of up to 2 years of follow-up postimplantation. The main outcome measures were mean relative and absolute reduction in diurnal intraocular pressure (IOP) compared to baseline. Secondary outcomes included patients with IOP ≤18 mmHg, patients with IOP reduction ≥20%, number of IOP-lowering medications, adverse events, and endothelial cell density loss. RESULTS: At the 2-year follow-up (n = 66), mean IOP was reduced from 23.8 ± 3.3 mmHg at baseline to 14.4 ± 4.5 mmHg (-39.3%; P < 0.0001). An IOP reduction of ≥20% was achieved in 89.4% of patients, with 84.8% having an IOP ≤18 mmHg. IOP-lowering medications were reduced from a mean of 2.4 ± 1.1 to 1.4 ± 1.4 (P < 0.0001), with 37.9% of patients being medication-free at 2 years. Mean endothelial cell density loss at 2 years was 6.2 ± 9.1% compared to baseline and no patient had a loss >30%. CONCLUSIONS: This meta-analysis demonstrates the favorable safety and efficacy profile of a supraciliary device implanted in a stand-alone, ab-interno procedure in patients with mild-to-moderate POAG. The data demonstrate that MINIject is a safe and effective, bleb-free treatment option for patients requiring low target IOP up to 2 years.

One-Year Outcomes of PreserfloTM MicroShunt Implantation versus Trabeculectomy for Pseudoexfoliation Glaucoma.

This retrospective, single-center study evaluates the safety and efficacy of PreserfloTM MicroShunt (MicroShunt) implantations compared to trabeculectomies (TETs) in patients diagnosed with pseudoexfoliation glaucoma (PEXG). A total of 31 eyes from 28 patients received a MicroShunt implantation, and 29 eyes from 26 patients received a TET. Surgical success was defined as an intraocular pressure (IOP) between 5 mmHg and 17 mmHg at the end of the follow-up period, no need for surgical revisions or secondary glaucoma surgery, and no loss of light perception. In the MicroShunt group, the mean IOP dropped from 20.8 ± 5.9 mmHg at baseline to 12.4 ± 2.8 mmHg (p < 0.0001) after one year. In the TET group, the mean IOP dropped from 22.3 ± 6.5 mmHg to 11.1 ± 3.7 mmHg (p < 0.0001) after 12 months. In both of the groups, the mean number of medications was reduced significantly (MicroShunt from 2.7 ± 1.2 to 0.2 ± 0.7; p < 0.0001 vs. TET from 2.9 ± 1.2 to 0.3 ± 0.9; p < 0.0001). Considering the success rates, 83.9% of the MicroShunt eyes achieved complete success, and 90.3% qualified for success at the end of the follow-up period. In the TET group, the rates were 82.8% and 93.1%, respectively. The postoperative complications were comparable between both groups. In conclusion, the MicroShunt implantation demonstrated non-inferiority regarding its efficacy and safety profile compared to TET in PEXG at a follow-up of one year.

EYEMATE-SC Trial: Twelve-Month Safety, Performance, and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure.

PURPOSE: Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to measure IOP throughout the entire day better. The novel EYEMATE-SC sensor (Implandata) is implanted in the suprachoroidal space to enable contactless continual IOP monitoring. The aim of the present study was to investigate the 1-year safety, performance, and accuracy of the EYEMATE-SC in patients with primary open-angle glaucoma undergoing simultaneous nonpenetrating glaucoma surgery (NPGS). DESIGN: Prospective, multicenter, open-label, single-arm, interventional clinical trial. PARTICIPANTS: Twenty-four eyes of 24 patients with primary open-angle glaucoma who were due to undergo NPGS (canaloplasty or deep sclerectomy). METHODS: An EYEMATE-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements at all postoperative visits through 12 months. MAIN OUTCOME MEASURES: Device position and adverse events. RESULTS: Fifteen eyes underwent canaloplasty, and 9 underwent deep sclerectomy. Successful implantation of the sensor was achieved in all eyes with no reported intraoperative difficulties. Through the 12-month follow-up, no device migration, dislocation, or serious device-related complications were recorded. A total of 536 EYEMATE-SC measurements were pairwise included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 0.8 mmHg (95% confidence interval [CI] of the limits of agreement [LoA], -5.1 to 6.7 mmHg). The agreement gradually improved, and from 3 months after surgery until the end of the follow-up, the mean difference was -0.2 mmHg (95% CI of LoA, -4.6 to 4.2 mmHg) over a total of 264 EYEMATE-SC measurements, and 100% of measurements were within ±5 mmHg of GAT. CONCLUSIONS: The EYEMATE-SC sensor was safe and well tolerated through 12 months. Moreover, it allowed accurate, continuous IOP monitoring. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

One-year outcomes of microshunt implantation in pseudoexfoliation glaucoma.

PURPOSE: To compare the safety and efficacy of microshunt implantation augmented with Mitomycin C in patients with pseudoexfoliation glaucoma (PEXG) and primary open-angle glaucoma (POAG). METHODS: In this retrospective, single centre, interventional study, 46 eyes of 41 patients with PEXG (20 eyes) and POAG (26 eyes) underwent microshunt implantation. Definition of failure was an intraocular pressure (IOP) lower than 5 or higher than 17mmHg on two consecutive visits, an IOP reduction lower than 20% on two consecutive visits, the need of surgical revisions or reoperations or loss of light perception. Outcome was rated as complete success if achieved without medication, otherwise as qualified success. Furthermore, postoperative complications and interventions were compared between the two groups. RESULTS: Patient demographics were similar, except for older age in the PEXG group (70.9±8.6 versus 77.6±8; p = 0.02). Mean IOP dropped from 21.5±5.8mmHg (PEXG) and 18.2±4.5mmHg (POAG) at baseline to 12.8±3.0mmHg (p<0.0001) and 12.9±4.2mmHg (p<0.0001), respectively, at one year. Mean number of medications were reduced from 2.8±1.3 to 0.3±0.8 for PEXG patients (p<0.0001) and from 2.7±1.3 to 0.3±0.8 for POAG patients (p<0.0001). At one year of follow-up 75.0% of PEXG patients achieved complete success and 80.0% qualified success. In the POAG group rates were 73.1% and 76.9%, respectively. Postoperative complications were comparable between both groups, except for higher rates of hypotony (p = 0.04) and choroidal detachment (p = 0.03) in the PEXG group. CONCLUSION: Microshunt implantation demonstrated similar efficacy results in PEXG and POAG eyes at a follow-up of 12 months. Higher rates of transient hypotony and choroidal detachment were observed in PEXG eyes.

Predictability of Refractive Outcome of a Small-Aperture Intraocular Lens in Eyes With Irregular Corneal Astigmatism.

PURPOSE: To compare different new-generation biometric formulas and ray-tracing for small-aperture intraocular lens (IOL) (IC-8; Acufocus, Inc) implantation in patients undergoing cataract and refractive lens exchange surgery with highly irregular corneas. METHODS: This monocenter study included 17 eyes of 17 patients with highly irregular corneas of different genesis. Biometric and topographic corneal data were assessed using the IOLMaster 700 (Carl Zeiss Meditec) and Pentacam (Oculus Optkigeräte GmbH). Prediction and absolute error were compared after 3 months based on manifest refraction. Furthermore, change of total corneal refractive power in different corneal pathologies was also evaluated. For IOL power calculation, three fourth-generation IOL formulas were compared (Haigis, SRK-T, and Barrett Universal II). The dataset was then checked against ray-tracing and analyzed to improve prediction error in these highly irregular corneas. RESULTS: All patients showed an improvement in visual acuity postoperatively with a mean spherical equivalent of -1.22 ± 0.49 diopters (D). Overall comparison of the three formulas showed the Haigis formula to be superior in terms of the smallest deviation of predictive and absolute error. IOL calculations with ray-tracing were possible in all eyes, but showed inaccurate results with keratometric values of 48.00 D and greater. CONCLUSIONS: The IC-8 IOL is well suited for patients with lens exchange in highly irregular corneas. The Haigis formula seemed to be the most accurate in the patient group. Ray-tracing confirmed the results of biometric formulas up to a keratometric value of 48.00 D and should be compared with standard biometric formulas to address corneal irregularities and to minimize refractive surprises after surgery. A comparison with ray-tracing in eyes with a keratometric value of greater than 48.00 D should not be considered due to the inaccurate results. [J Refract Surg. 2021;37(5):312-317.].

[Intraocular lens opacification after combined cataract and minimally invasive glaucoma surgery (MIGS)]. / Trübung der Intraokularlinse nach kombinierter Katarakt- und minimal-invasiver Glaukomchirurgie (MIGS).

A visual deterioration due to opacification of the intraocular lens was observed 3 weeks after uncomplicated combined minimally invasive glaucoma and cataract surgery. Due to the patient's failure to apply the prescribed postoperative local anti-inflammatory eyedrops, homogeneous fibrin coating on the anterior surface of the lens occurred, as well as early scarring of the filtering bleb. We performed needling with 5­fluorouracil and lens polishing with the Nd:YAG laser to achieve sufficient pressure control and vision improvement.

Safety and efficacy of a small-aperture capsular bag-fixated intraocular lens in eyes with severe corneal irregularities.

PURPOSE: To implant a small-aperture intraocular lens (IOL) (IC-8) in eyes with severe corneal irregularities to reduce higher-order aberrations and provide better central visual acuity. SETTING: University Hospital, LMU Munich, Germany. DESIGN: Prospective nonrandomized interventional case series. METHODS: Eyes with severe corneal irregularities due to keratoconus, previous penetrating keratoplasty, status postradial keratotomy, or scarring after ocular trauma were enrolled. Exclusion criteria were progressive keratoconus, pseudoexfoliation, glaucoma, maculopathy, reduced endothelial cells (<1800 cells/mm), and central corneal opacity. Conventional phacoemulsification with implantation of the small-aperture IOL was performed. The primary efficacy endpoint was corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), and uncorrected near visual acuity (UNVA). Secondary endpoints were life quality assessment using the Visual Function Questionnaire-25 and determination of the refractive defocus curve. RESULTS: Seventeen eyes of 17 patients were enrolled. In all 17 patients, CDVA improved from 0.37 ± 0.09 to 0.19 ± 0.06 logarithm of the minimum angle of resolution (logMAR) 3 months postoperatively (P < .0001). Similarly, postoperative UDVA, UIVA, and UNVA improved significantly in 100%, 88%, and 88%, respectively. The defocus curve showed best results at 0.17 logMAR with a defocus of -0.5 diopter. In addition, overall life quality analyses reported less difficulty with activities under reduced optical phenomena conditions. CONCLUSIONS: The small-aperture IOL was a useful option in eyes with severe corneal irregularities, had a high safety index and a high satisfaction rate, and can lead to better visual quality in these cases. Further studies are needed to improve power calculation of this IOL.

Secondary intraocular lens implantation: a large retrospective analysis.

PURPOSE: To investigate preoperative ocular risk factors and indications for secondary intraocular lens (IOL) implantation and compare postoperative complications, visual and refractive outcomes in a tertiary referral center. METHODS: Patients older than 14 years that underwent secondary IOL implantation and had a minimum follow-up of 3 months were enrolled in this retrospective case series. Preoperative ocular risk factors, indications for surgery, postoperative complications, and visual and refractive outcomes including prediction error (PE) and absolute error (AE) were evaluated. IOLs were fixated in following positions: anterior chamber (AC), retropupillary iris-claw (IC), sulcus, and capsular bag or sclera. RESULTS: One-hundred eighty-two eyes of 174 patients with mean follow-up of 17 ± 13.6 months were evaluated. Leading cause for surgery was IOL dislocation (75%), followed by secondary aphakia (19%) and IOL opacifications (6%). Previous vitrectomy was the major preoperative ocular risk factor (43%). Mean corrected distance visual acuity improved from preoperative 0.68 ± 0.55 to 0.42 ± 0.31LogMAR by the last follow-up (p = 0.001). PE and AE differed highly depending on the indication for surgery (p = 0.041 and p = 0.008, respectively) and the IOL fixation (p = 0.011 and p = 0.028, respectively), with IC-IOLs showing the lowest PE and AE. Postoperative AC-hemorrhage occurred mainly after IC-IOLs (p = 0.003), and postoperative hypotony was significantly higher in eyes with previous uveitis (p = 0.026). CONCLUSIONS: Previous vitrectomy seems to be a major underreported risk factor in eyes that undergo secondary IOL implantation. Refractive outcomes depend on indication for surgery and fixation type, with retropupillary IC-IOLs providing the best refractive results, though not statistically significant compared to other IOL positions.

Prospective, randomized, double-blind trial to investigate the efficacy and safety of corneal cross-linking to halt the progression of keratoconus.

BACKGROUND: Corneal cross-linking is widely used to treat keratoconus. However, to date, only limited data from randomized trials support its efficacy. METHODS: The efficacy and safety of corneal cross-linking for halting progression of keratoconus were investigated in a prospective, randomized, blinded, placebo controlled, multicentre trial. Twenty-nine keratoconus patients were randomized in three trial centres. The mean age at inclusion was 28 years. Longitudinal changes in corneal refraction were assessed by linear regression. The best corrected visual acuity, surface defects and corneal inflammation were also assessed. These data were analysed with a multifactorial linear regression model. RESULTS: A total of 15 eyes were randomized to the treatment and 14 to the control group. Follow-up averaged 1098 days. Corneal refractive power decreased on average (+/-standard deviation) by 0.35 +/- 0.58 dioptres/year in the treatment group. The controls showed an increase of 0.11 +/- 0.61 dioptres/year. This difference was statistically significant (p = 0.02). CONCLUSIONS: Our data suggest that corneal cross-linking is an effective treatment for some patients to halt the progression of keratoconus. However, some of the treated patients still progressed, whereas some untreated controls improved. Therefore, further investigations are necessary to decide which patients require treatment and which do not. TRIAL REGISTRATION: NCT00626717, Date of registration: February 20, 2008.

Large choroidal melanoma diagnosed after cataract surgery.

A dense cataract prevents detailed fundus examination which may lead to delayed diagnosis of undiscovered intraocular pathology before cataract surgery. We report two cases where large choroidal melanomas were diagnosed after cataract surgery and/or Nd:Yag laser capsulotomy. In the first case, a dense cataract prevented proper examination of the fundus of an 84-year-old female. A brownish choroidal lesion was seen after cataract surgery and diagnosed as postoperative choroidal detachment. As this lesion persisted over months, the patient was sent to our hospital for evaluation where a diagnosis of choroidal melanoma with extrascleral growth was made and an enucleation with implantation of a dermis-fat graft was performed without complication 10 days later. In the second case, a 58-year-old female patient had Nd:Yag laser treatment 2 years after cataract surgery had been performed. During fundus examination 1 day after treatment, the ophthalmologist noticed a choroidal lesion which he suspected to be a reaction to the laser treatment and referred the patient to our hospital where a diagnosis of a mushroom-shaped choroidal melanoma with serous retinal detachment was made. These cases show that preoperative evaluation of the posterior segment prior to cataract surgery or other therapeutic interventions is essential in order to identify any pathology. In case of a dense cataract, additional imaging such as ultrasound sonography is recommended in order to exclude intraocular lesions and to visualize the optic disc in suspected glaucoma.

In vivo confocal microscopy of normal conjunctiva and conjunctivitis.

PURPOSE: To analyze the appearance of normal conjunctiva and conjunctival inflammation by in vivo confocal microscopy. METHODS: Conjunctiva of 15 normal patients and 21 patients with conjunctivitis including bacterial, papillary, follicular, granulomatous, and cicatrizing disease were analyzed by the Heidelberg retina tomograph (HRTII)/Rostock cornea modul (RCM). RESULTS: Scans of normal bulbar and tarsal conjunctiva corresponded well to the established anatomy except for a prominent, thickened epithelial basement membrane observed by in vivo microscopy. Presumed goblet cells were visible throughout the conjunctival epithelium. Adenoid structures and hair follicles were discernible in the tarsal conjunctiva in vivo. Conjunctival perfusion could be observed directly. Acute and chronic inflammatory cells, conjunctival papillary, and follicular reactions, as well as conjunctival cicatrization, could be discriminated. In a patient with conjunctival granuloma, in vivo confocal microscopy disclosed suture material inside the lesion. CONCLUSION: Confocal microscopy using near-infrared laser light is a useful new tool in the analysis of conjunctival tissue in vivo. It is a valuable aid in the differential diagnosis of conjunctival inflammation and thus may guide therapeutical decisions.

In vivo confocal microscopy of filtering blebs after trabeculectomy.

OBJECTIVES: To analyze filtering blebs after trabeculectomy by means of in vivo confocal microscopy and to correlate the images with clinical bleb appearance and function. METHOD: In vivo confocal microscopy using the Heidelberg Retina Tomograph/Rostock Cornea Module (Heidelberg Engineering, Heidelberg, Germany) was performed in 53 filtering blebs in 45 patients 6 days to 30 years postoperatively. RESULTS: In vivo confocal microscopic findings significantly correlated with good bleb function included the number of epithelial microcysts (P = .03), a large total stromal cyst area (P = .009), the absence of encapsulated stromal cysts (P = .002), minimal vascularization (P = .05), and the absence of tortuous conjunctival vessels (P = .01). In contrast, a hyperreflective condensed bleb stroma was significantly associated with bleb failure (P<.001). Bleb stroma mainly consisting of a rarified collagenlike network was significantly linked to trabeculectomy performed with mitomycin C (P = .001). Epithelial and stromal inflammation were observed at a median of 1 and 4 months after surgery, respectively. CONCLUSIONS: In vivo confocal microscopy using the Heidelberg Retina Tomograph/Rostock Cornea Module permits diagnostic imaging of filtering blebs and differentiation between good and insufficient bleb function. Moreover, the postoperative inflammatory reaction can be monitored directly for adapted postoperative anti-inflammatory treatment.

In vivo confocal microscopy of pigmented conjunctival tumors.

PURPOSE: To analyze the appearance of conjunctival pigmented tumors as seen by in vivo confocal microscopy. METHODS: Twenty-eight pigmented conjunctival tumors including 6 nevi, 13 acquired melanoses, 7 conjunctival melanomas, and 2 extrascleral growths of uveal melanomas were examined by in vivo confocal microscopy using the Heidelberg Retina Tomograph (HRTII)/Rostock Cornea Modul (RCM). Confocal images were analyzed using predefined criteria by an observer masked to final histological diagnosis and a preliminary diagnosis was established. After excision, histology and immunohistochemistry using antibodies against S-100, Melan-A, HMB-45, Ki-67, CD3, and CD68 were performed in all specimens and compared with in vivo confocal images of the same lesions. RESULTS: Confocal microscopy images confirmed typical histopathological features of conjunctival pigmented tumors. Nest or diffuse collections of medium-sized uniform hyper- or hyperreflective cells in the stroma and stromal cysts lined with a multilayered epithelium were visible in 100% of conjunctival nevi. Small dendritic cells were typically observed in 100% of primary acquired melanoses (PAM) without atypia and in 2 out of 6 nevi. Large networks of hyperreflective dendritic cells were present in 100% of PAM with atypia. Whereas images of PAM without atypia and secondary complexion-associated melanosis showed hyperreflective granules confined to the basal epithelium in 67% of lesions, PAM with atypia presented with hyperreflective granules and patches throughout the epithelium in all cases. Malignant melanomas of the conjunctiva and extrascleral growths of uveal melanomas demonstrated large hyperreflective cells with prominent nuclei and nucleoli. In vivo confocal microscopy showed a sensitivity of 89% and a specificity of 100% to establish the correct diagnosis of conjunctival melanoma compared with histology. CONCLUSIONS: High correlations were found between in vivo confocal microscopy using near-infrared laser light and histology in the diagnosis of pigmented conjunctival lesions. In vivo confocal microscopy seems to be a valuable new tool in the differential diagnosis and follow-up of pigmented conjunctival tumors. It does not replace histology, but may assist in performing guided biopsy in tumors suspected clinically and/or with in vivo microscopy. In addition, in vivo confocal microscopy may support the clinical diagnosis of extrascleral involvement in uveal melanoma.