Mid-term surgical success after transscleral ab interno glaucoma gel stent implantation.

PURPOSE: To investigate the surgical success and efficacy of XEN45 implantation (XEN45 µm, AbbVie Inc., USA) with and without combined cataract surgery up to the first 5 years. METHODS: In a prospective observational monocentric trial, 192 eyes of 157 patients with open-angle glaucoma received either XEN45 implants only (solo surgery group) or combined surgery/cataract surgeries (combined surgery group). Surgical success (qualified and full success; IOP-limit: ≤12, 15, 18, 21 mmHg), time to secondary IOP-lowering procedure, IOP and number of IOP-lowering medications were analysed for 1, 2, 3, 4 and 5 years. RESULTS: Compared to baseline, IOP (24.1 ± 8.1 to 12.6 ± 2.8 mmHg, -48%, p < 0.001) and the number of IOP-lowering medications (3.0 ± 1.0 to 1.5 ± 1.2, -50%, p < 0.001) decreased significantly at 5 years. Although no differences between IOP and the number of IOP-lowering medication courses between the groups were detected at 5 years (p > 0.11), the combined procedure (63%, 37%) showed better success rates compared to the solo procedure (36%, 13%) in the definition IOP ≤18 and ≤12 mmHg (p = 0.035, 0.028). Solo XEN45 procedures had a higher rate of secondary IOP-lowering procedures compared to combined XEN45 cataract procedures (hazard ratio: 2.02, 95%CI: 1.03-3.97, p = 0.04). Twenty per cent of the eyes, including both procedures, required a secondary IOP-lowering procedure within 5 years. CONCLUSIONS: The XEN45 implant is effective in lowering IOP and the number of IOP-lowering medications in patients with open-angle glaucoma in the mid-term. Comparing XEN45 implant results with the results of trabeculectomy available in current literature, we speculate that there might be a higher surgical success rate without medications in favour of trabeculectomy.

Radius-Maumenee syndrome: A case series with a long-term follow-up.

The aim of the case series is to highlight the surgical challenges experienced like failed intervention, choroidal effusion, a postoperative cystoid macular oedema, and describe treatment options for Radius-Maumenee syndrome. Authors reported on 3 bilateral cases of Radius-Maumenee syndrome which underwent medical treatment, trabeculectomy with Mitomycin C, implantation with XEN45, Ahmed glaucoma valve, Baerveldt glaucoma implant, and cyclophotocoagulation.

Five-year follow-up of corneal endothelial cell density after transscleral ab interno glaucoma gel stent implantation.

PURPOSE: This study investigates the course of the endothelial cell density over a period of 5 years after XEN45 implantation (XEN45µm, Allergan Plc., USA) with or without combined cataract surgery. METHODS: This is a prospective, cross-sectional, monocentric, non-randomized clinical trial with the intention to treat a population of the University Eye Clinic Glaucoma Service Salzburg. One hundred and fifty-five eyes with preoperative central corneal endothelial cell counts were subjected to XEN45 implantation with (combined surgery group) or without (solo surgery group) combined cataract surgery. Endothelial cell density was measured at 3 corneal positions. XEN45 location parameters were determined with anterior segment OCT and gonioscopy. RESULTS: In the combined surgery group, a significant reduction of central endothelial cell count was found at years 2 and 4 when compared to baseline (p = 0.001 and p = 0.02, n = 86), whereas at years 1, 3, and 5, no change was detected (all p > 0.09). The median reduction of endothelial cell count was - 79 (95% CI: - 183 to - 9) and - 93 (95% CI: - 220 to 23) cells at years 2 and 4, respectively. In the solo surgery group (n = 69), no significant change in endothelial cell counts was detected at any time during the 5-year evaluation period (all p > 0.07). Explorative data analyses revealed that XEN45 location parameters did not significantly influence the course of endothelial cell count over time. CONCLUSIONS: Endothelial cell loss after XEN45 implantation seems to be low. The present data suggest no impact on the position of the implant with regard to central endothelial cell counts in this study.

Two-year efficacy after first transscleral controlled cyclophotocoagulation in patients with and without pseudoexfoliation.

PURPOSE: Transscleral controlled cyclophotocoagulation (COCO) is a transscleral 810-nm diode laser cyclophotocoagulation that automatically adjusts the applied laser energy utilizing an optical feedback loop. The present study investigates the influence of pseudoexfoliation (PEX) on the efficacy of COCO in a Caucasian study population. METHODS: Retrospective data from 130 consecutive eyes were analyzed during a 2-year follow-up. Baseline characteristics, intraocular pressure (IOP), number of IOP-lowering medications, visual field, best-corrected visual acuity (BCVA), and secondary surgical interventions (SSI) were analyzed. The primary endpoint was IOP reduction at M24 compared to baseline, and the secondary endpoints were IOP course, reduction of IOP-lowering medications, surgical success, and IOP-lowering SSIs stratified by PEX and baseline IOP. RESULTS: IOP reductions of -35, -39, -25, -25, -23, -34, and -36% could be achieved from baseline to D1, W1, M1, M3, M6, M12, and M24 (all p < 0.001), respectively, while there was a significant overall reduction over time (p < 0.001) in the number of topical IOP-lowering medications postoperatively. The proportion of eyes requiring additional systemic IOP-lowering medication reduced from 31 to 0% at M24 (p = 0.025). Eyes without PEX and IOP < 30 mmHg at baseline had the lowest risk for IOP-lowering SSIs (p < 0.03). BCVA dropped at M12 (0.25 [95% CI: 0.12-0.38]), and the drop persisted during the following 12 months. CONCLUSION: The present study demonstrates a midterm IOP-lowering effect after COCO while reducing the burden for topical and systemic IOP-lowering medications. Patients without PEX and IOP < 30 mmHg have a lower risk of SSI. The procedure per se cannot be excluded as causative for the decreased postoperative BCVA. Further prospective investigations are suggested.

Change in visual acuity 12 and 24 months after transscleral ab interno glaucoma gel stent implantation with adjunctive Mitomycin C.

PURPOSE: To analyze changes in best-corrected visual acuity (BCVA) after implantation of the transscleral ab interno glaucoma gel stent (XEN Gel Stent; Allergan, Dublin) in patients with open-angle glaucoma. METHODS: In a single-center, prospective, non-randomized study of 137 eyes with open-angle glaucoma which underwent implantation with XEN, 69 eyes underwent XEN implantation alone (group 1) and 68 eyes underwent XEN implantation and cataract surgery (group 2). BCVA (Bailey-Lovie chart, logMAR scale) was evaluated at baseline, postoperative day 1, weeks 1 and 2, and months 1, 3, 6, 12, and 24. Risk factors for decline in BCVA were analyzed in multivariate models. RESULTS: Baseline BCVA in group 1 was 0.21 ± 031; the group's mean BCVA did not change at any postoperative visit, although a ≥ 2-line loss of BCVA was detected in 15% (95% CI 7-29%) and 4% (95% CI 0-20%) after months 12 and 24, respectively. Baseline BCVA in group 2 was 0.33 ± 031; vision increased significantly at months 3 (0.22 ± 0.29, p = 0.015), 6 (0.20 ± 0.26, p = 0.006), 12 (0.18 ± 0.29, p = 0.001), and 24 (0.18 ± 0.29, p = 0.005). A ≥ 2-line loss of BCVA was reported in 4% (95% CI 1-15%) and 7% (95% CI 1-24%) after months 12 and 24, respectively. CONCLUSIONS: There was no deterioration of BCVA in group 1; those in group 2 had an overall significant increase in BCVA. BCVA decrease was lower than is typically reported in the literature post-trabeculectomy.

Effect of the outer stent position on efficacy after minimally invasive transscleral glaucoma gel stent implantation.

PURPOSE: The outer stent lumen can be located either deeper (in or under Tenon's layer) or more superficially in the conjunctival stroma after the transscleral XEN Glaucoma Gel Microstent (XEN-GGM; Allergan Plc., USA) implantation. The present study aimed to investigate the effect of the postoperative conjunctival implant position on surgical success and intraocular pressure (IOP) after XEN-GGM. METHODS: Prospective data from 66 consecutive open-angle glaucoma eyes of 54 patients were collected preoperatively and 1 and 2 weeks, and 1, 6 and 12 months postoperatively. The layer of implantation was determined in the first month postoperatively as intra- and subtenon or intraconjunctival depending on the location of the outer lumen of the stent in OCT (Visante OCT; Zeiss, Germany). Primary outcome measures were differences in relative IOP reduction at 12 months between the two groups. Further, complete and qualified surgical success, number of secondary needlings and number of IOP-lowering medications and absolute IOP were assessed. RESULTS: Relative IOP reduction was higher in intra- and subtenon group (n = 37/66, 56%) at week 1 (-54% versus -19%, p < 0.001), week 2 (-39% versus -21%, p = 0.02), month 1 (-42% versus -28%, p = 0.035) and month 12 (-39% versus -24%, p = 0.024). The mean absolute IOP was lower in intra- and subtenon group at week 1 (10.8 [95%CI, 8.8-14.1] versus 16.6 [95%CI, 14.1-19.0] mmHg, p < 0.001) and months 12 (13.9 [95%CI, 12.4-15.4] versus 16.7 [95%CI, 14.6-18.8] mmHg, p = 0.041). At month 6, a lower burden for IOP-lowering medication was shown for the intra- and subtenon group (0.2 ± 0.5 versus 1.0 ± 1.1, p = 0.034). The mean number of secondary needlings, which were done in 47/66 (71%) of the eyes, was lower in the intra- and subtenon group in the first year (1.9 ± 1.7 versus 1.2 ± 1.2, p = 0.03). Qualified surgical success was higher in the intra- and subtenon group (90% versus 61%, p = 0.01) after 1 year. CONCLUSION: The present study demonstrates a higher efficacy achieved with lower secondary needling rates in deeper implant positions in conjunctiva after XEN-GGM.

Longitudinal bleb morphology in anterior segment OCT after minimally invasive transscleral ab interno Glaucoma Gel Microstent implantation.

PURPOSE: Like the classic trabeculectomy, the minimally invasive, ab interno XEN Glaucoma Gel Microstent (XEN-GGM) creates a filtration bleb in the conjunctiva. The goal of this study was to investigate internal bleb morphology over time with anterior segment optical coherence tomography (AS-OCT) after XEN-GGM implantation. METHODS: In a prospective, single-centre, single-armed cohort study, blebs were characterized using AS-OCT in 78 eyes of 60 patients at day 1, at weeks 1 and 2 and at months 1, 3, 6, 9 and 12 after XEN-GGM implantation in patients with open-angle glaucoma. Morphological bleb characteristics were correlated with IOP and surgical success. RESULTS: Anterior segment optical coherence tomography data indicate early and late bleb changes in the course of 12 months. Uniform blebs in AS-OCTs showed higher IOPs at all examinations between week 1 (17.7 ± 4.8 mmHg versus 11.3 ± 7.1 mmHg, p = 0.001) and month 3 (16.4 ± 6.1 versus 13.4 ± 6.1, p = 0.04). Subconjunctival tissue separation bleb morphology was associated with lower mean IOPs during the course of 12 months (r = -0.75, p = 0.031). Predictors for surgical failure at month 12 were microcystic multiform bleb morphology in AS-OCT at month 3 (60% versus 15%, relative risk 4.0, p = 0.043) and uniform bleb morphology at month 9 (33% versus 23%, relative risk 1.4, p = 0.015). CONCLUSION: Bleb appearance after XEN surgery seems to be different to classic trabeculectomy literature. The present data suggest correlation of IOP and surgical long-term success with bleb morphology in AS-OCT. Prevalence of small diffuse cysts is directly associated with lower IOPs, while cystic encapsulation at 3 months predicts higher surgical failure.

Four-year results of a minimally invasive transscleral glaucoma gel stent implantation in a prospective multi-centre study.

IMPORTANCE: The transscleral XEN Glaucoma Gel Microstent (XEN-GGM, Allergan Plc., Parsippany, New Jersey) is implanted by a minimally invasive ab interno technique. BACKGROUND: The present study aims to assess the long-term clinical outcomes in patients after XEN-GGM implantation. DESIGN: This prospective, non-randomized, multi-centred study was conducted in three countries (Austria, Canada and Germany). PARTICIPANTS: Sixty-four consecutive eyes of 64 patients with open angle glaucoma received the XEN-GGM (63 µm) without Mitomycin C. Thirty-five (55%) were solo procedures, and 29 (45%) were combined with cataract surgery. METHODS: Visits were planned at baseline, 6 months, 1, 2, 3 and 4 years postoperatively. MAIN OUTCOME MEASURES: The main outcome measures were mean intraocular pressure (IOP), mean number of IOP lowering medication. Secondary outcome parameters were: visual acuity, visual fields and complete surgical failure (defined as presence of a secondary IOP lowering procedure or loss of light perception) at 4 years, postoperatively. RESULTS: Mean best-medicated baseline IOP was 22.5 ± 4.2 mmHg and decreased significantly to 13.4 ± 3.1 mmHg 4 years postoperatively (-40%, n = 34, P < 0.001). Mean number of IOP lowering medication decreased significantly from 2.4 ± 1.3 preoperatively to 1.2 ± 1.3 (-50%, n = 34, P < 0.001) postoperatively. Visual field mean deviation showed no significant change between preoperative and postoperative examinations. Complete surgical failure rate per year was 10%. CONCLUSIONS AND RELEVANCE: The XEN-GGM resulted in lower IOP and a reduction in medications from baseline over 4 years of follow-up. There was no detectable decrease in visual fields over the study. The surgical failure rate is comparable to other filtration surgeries.

Phacoemulsification combined with a new ab interno gel stent to treat open-angle glaucoma: Pilot study.

PURPOSE: To study the effect on intraocular pressure (IOP) of implanting a new gelatin stent at the time of cataract surgery in the treatment of open-angle glaucoma (OAG). SETTING: Multicenter university and private-practice settings. DESIGN: Nonrandomized prospective clinical trial. METHODS: The implantation of 2 models of a gelatin stent (Xen140 and Xen63) was performed at the time of cataract surgery without mitomycin-C. Complete success was defined as a postoperative IOP of less than 18 mm Hg and more than a 20% reduction in IOP at 12 months without glaucoma medication. Failure was defined as loss of light perception vision or worse, a need for additional glaucoma surgery, or less than a 20% reduction in the IOP from baseline. RESULTS: The study included 37 eyes of 37 patients. The mean preoperative IOP was 22.4 mm Hg ± 4.2 (SD) on 2.5 ± 1.4 medication classes. Twelve months postoperatively, the mean IOP was reduced to 15.4 ± 3.0 mm Hg on 0.9 ± 1.0 medication classes (P < .0001). This resulted in a qualified success of 85.3% and a complete success rate off medications of 47.1%. There were no failures. CONCLUSION: Cataract surgery combined with implantation of the gelatin stent resulted in a significant reduction in IOP in eyes with OAG. FINANCIAL DISCLOSURE: Dr. Sheybani has received travel reimbursement from Aquesys, Inc. Dr. Ahmed is a paid consultant to Aquesys, Inc. No other author has a financial or proprietary interest in any material or method mentioned.

Vector analysis of astigmatism correction after toric intraocular lens implantation.

PURPOSE: To determine astigmatic changes by vector analysis and postoperative refractive and visual outcomes after implantation of the monofocal aspheric bitoric AT Torbi 709M toric intraocular lens (IOL). SETTING: Three centers in Salzburg, Austria, and Alicante and San Sebastián, Spain. DESIGN: Prospective interventional case series. METHODS: Preoperative and postoperative visual acuity, subjective and objective refractions, and corneal radii using a topographer were examined in all patients. All patients had postoperative examinations within the first week and at 6 to 12 weeks. Astigmatic changes were evaluated using the Alpins vector method based on 3 fundamental vectors as follows: target induced astigmatism (TIA), surgically induced astigmatism (SIA), and difference vector. The various relationships between these 3 vectors were calculated, providing an extensive description of the astigmatic correction achieved. RESULTS: Eighty-eight eyes (71 patients) were included. Postoperatively, refractive cylinder was reduced significantly (P < .001), concurrent with visual improvement. The mean magnitude of the SIA vector (2.54 diopters [D] ± 1.21 [SD]) was slightly higher than the mean magnitude of the TIA vector (2.37 ± 1.15 D) at the last follow-up. The mean difference vector was 0.46 ± 0.46 D, the mean magnitude of error was 0.16 ± 0.46 D, and the mean correction index was 1.09 ± 0.21, all indicating minimal overcorrection at 3 months that remained stable during the follow-up. CONCLUSION: Implantation of the toric IOL was safe and effective for the treatment of eyes with cataract in combination with preexisting regular corneal astigmatism over a short-term follow-up. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Aqueous humor ferritin in hereditary hyperferritinemia cataract syndrome.

PURPOSE: Hereditary hyperferritinemia cataract syndrome (HHCS) is a rare autosomal dominant hereditary disease, characterized by hyperferritinemia but with absence of body iron excess and early onset of bilateral cataracts. Although 5- to 20-fold increased serum ferritin concentrations have been reported in HHCS patients, data of ferritin levels in aqueous humor have not been obtained. We therefore aimed to investigate the ferritin levels in aqueous humor and serum and further present histological and ultrastructural data of the lens. METHODS: During cataract extraction and intraocular lens implantation, aqueous humor and lens aspirate of a 37-year-old HHCS patient were obtained from both eyes. Ferritin levels in serum and aqueous humor were quantitatively analyzed via immunoassays in the HHCS patient and healthy control subjects (n = 6). Lens aspirate in HHCS was analyzed histologically and at the ultrastructural level. Further, genetic mutation screening by polymerase chain reaction and DNA sequencing in blood was performed. RESULTS: Serum ferritin levels in the control group were 142.2 ± 38.7 µg/L, whereas in the HHCS patient, this parameter was excessively increased (1086 µg/L). Analysis of ferritin in aqueous humor revealed 6.4 ± 3.8 µg/L in normal control subjects and 146.3 µg/L (OD) and 160.4 µg/L (OS) in the HHCS patient. DNA analysis detected a C>A mutation on position +18, a T>G mutation on position +22, a T>C mutation on position +24, and a T>G polymorphism on position +26 in the iron-responsive element of the light-chain ferritin (L-ferritin) gene. CONCLUSIONS: In the HHCS patient, a 23-fold (OD) to 25-fold (OS) increased aqueous humor ferritin level was detected. Therefore, the formation of bilateral cataract in HHCS is most likely a result of elevated aqueous humor ferritin. In addition, a novel mutation in this rare disease in the iron-responsive element of L-ferritin gene is reported.

Reading performance after implantation of a modified corneal inlay design for the surgical correction of presbyopia: 1-year follow-up.

PURPOSE: To evaluate change in different reading performance parameters after monocular ACI7000PDT corneal inlay implantation for the improvement of near and intermediate vision. DESIGN: Prospective, interventional case series. METHODS: Twenty-four patients were scheduled for corneal inlay implantation in the nondominant eye in a university outpatient surgery center. Naturally emmetropic and presbyopic patients between 45 and 60 years of age, with uncorrected distance visual acuity of at least 20/20 in both eyes, without any additional ocular pathology were eligible for inclusion. Bilateral uncorrected reading acuity, mean and maximum reading speed, and smallest log-scaled print size were evaluated with the standardized Radner Reading Charts. Measurements of reading parameters and reading distance were performed with the Salzburg Reading Desk (SRD). Minimum postoperative follow-up was 12 months. RESULTS: The reading desk results showed significant changes in each parameter tested. After 12 months the mean reading distance changed from the preoperative value of 46.7 cm (95% CI: 44.1-49.3) to 42.8 cm (95% CI: 40.3-45.3, P < .004), and the mean reading acuity "at best distance" improved from 0.33 logRAD (95% CI: 0.27-0.39) to 0.24 logRAD (95% CI: 0.20-0.28, P < .005). Mean reading speed increased from 141 words per minute (wpm, 95% CI: 133-150) to 156 wpm (95% CI: 145-167, P < .003), maximum reading speed increased from 171 wpm (95% CI: 159-183) to 196 wpm (95% CI: 180-212, P = .001), and the smallest print size improved from 1.50 mm (95% CI: 1.32-1.67) to 1.12 mm (95% CI: 1.03-1.22, P < .001). CONCLUSIONS: After ACI7000PDT implantation, there were significant changes in all tested reading performance parameters in emmetropic presbyopic patients. These 1-year results indicate that the inlay seems to be an effective treatment for presbyopia.

Small-aperture corneal inlay for the correction of presbyopia: 3-year follow-up.

PURPOSE: To report the 3-year postoperative safety and efficacy outcomes of the Acufocus corneal inlay. SETTING: University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. DESIGN: Prospective nonrandomized noncomparative cohort study. METHODS: The corneal inlay was implanted in the nondominant eye of naturally emmetropic presbyopic patients. Refraction, uncorrected near (UNVA), intermediate (UIVA), and distance (UDVA) visual acuities; corrected distance visual acuity (CDVA); contrast sensitivity; visual fields; subjective patient satisfaction and symptoms; and operative and postoperative adverse events and complications were evaluated. RESULTS: The study enrolled 32 patients. The mean UNVA improved from Jaeger (J) 6 preoperatively to J1 at 3 years and the mean UIVA, from 20/40 to 20/25, respectively. At 3 years, 97% of eyes had a UNVA of J3 or better and 91% had a UIVA of 20/32 or better. The mean UDVA was 20/20, with all eyes achieving 20/32 or better. Nine eyes (28.3%) lost 1 line of CDVA, 1 eye (3.1%) lost more than 2 lines (3.8 lines), and 3 eyes (9.3%) gained 1 line. No inlay was explanted, and no inflammatory reactions were observed. At 3 years, 15.6% of patients reported severe night-vision problems and 6.3% (versus 87.5% preoperatively) reported being dependent on reading glasses. CONCLUSIONS: These 3-year results support the safety and efficacy of the corneal inlay to correct presbyopia in naturally emmetropic presbyopic patients. However, despite a significant gain in UNVA and UIVA, 28.3% of patients lost 1 line of CDVA.

One-year visual outcomes and patient satisfaction after surgical correction of presbyopia with an intracorneal inlay of a new design.

PURPOSE: To evaluate the safety and efficacy of the third-generation Kamra corneal inlay (ACI 7000PDT) implanted monocularly in corneal pockets of emmetropic presbyopic patients to improve near and intermediate vision. SETTING: University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. DESIGN: Cohort study. METHODS: The corneal inlay was implanted in the nondominant eye over the line of sight by creating a corneal pocket with a femtosecond laser. The minimum postoperative follow-up was 12 months. Distance, intermediate, and near visual acuities were assessed over the follow-up. Other examinations included slitlamp evaluation, central keratometry, computerized corneal topography, endothelial cell count, and central corneal thickness. Patients completed satisfaction questionnaires preoperatively and 3, 6, and 12 months postoperatively. RESULTS: The study evaluated 24 patients. After a mean follow-up of 12 months, 92% of patients read Jaeger (J) 3 or better with the surgical eye, the mean binocular uncorrected near visual acuity improved from J5 preoperatively to J2, and the mean binocular uncorrected intermediate visual acuity was 20/20 (67% ≥ 20/20). At 12 months, the mean uncorrected distance visual acuity was 20/20 in the surgical eye and 20/16 binocularly. Patients reported no change in distance vision, and their need for reading glasses decreased significantly (P<.001). No inlay was explanted and or recentered during the reported follow-up. CONCLUSION: The new corneal inlay was a safe and effective treatment for presbyopia over a 1-year follow-up.

Central and peripheral corneal iron deposits after implantation of a small-aperture corneal inlay for correction of presbyopia.

PURPOSE: To describe central and peripheral corneal iron deposition after implantation of the AcuFocus corneal inlay (ACI 7000, AcuFocus Inc) for the surgical correction of presbyopia. METHODS: Patients who underwent inlay implantation between September 2006 and May 2007 and displaying corneal iron deposits were enrolled in the study. RESULTS: Eighteen (56%) eyes of 32 patients developed corneal iron deposition within 36 months after corneal inlay implantation. One (5.5%) eye had a central spot-like iron deposition only, 10 (55.5%) eyes had formation of deposits in a half-moon shape in the inferior cornea parallel to the outer margin of the inlay or a complete circular ring formation, and 7 (39%) eyes demonstrated deposits in both areas. The median interval between implantation and diagnosis of corneal iron deposition was 18 ± 9 months. CONCLUSIONS: Corneal iron deposition can develop in different shapes after implantation of the small-aperture ACI 7000. Alterations in tear film thickness, its composition, and corneal epithelial basal cell storage, resulting from changes in corneal topography, may be contributing factors for these specific iron depositions.

Postoperative bilateral reading performance with 4 intraocular lens models: six-month results.

PURPOSE: To compare bilateral reading performance within the first 6 months after implantation of 4 intraocular lens (IOL) models. SETTING: Vissum-Instituto de Oftalmológico de Alicante, Alicante, Spain, and University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. DESIGN: Comparative case series. METHODS: Patients had bilateral phacoemulsification and implantation of Acri.Smart 48S monofocal, Acrysof Restor SN6AD3 apodized multifocal, Acri.LISA 366D diffractive multifocal, or Rezoom refractive multifocal IOLs. Bilateral reading performance with and without near correction was evaluated preoperatively and postoperatively using the Salzburg Reading Desk. RESULTS: The study comprised 304 eyes of 152 patients 51 to 90 years old. All groups had a significant improvement in uncorrected and corrected distance visual acuities postoperatively (P≤.01). The apodized multifocal and diffractive multifocal groups had significantly better uncorrected reading acuity than the monofocal and refractive multifocal groups 1 month and 6 months postoperatively (P<.01). Uncorrected reading speed was significantly worse in the refractive multifocal group than in the monofocal group at 1 month (P<.01). The monofocal group had the greatest uncorrected reading distance at 1 month and 6 months (P<.01). CONCLUSION: Multifocal IOLs with a diffractive component provided a comparable reading performance that was significantly better than the one obtained with refractive multifocal and monofocal IOLs.

Reading performance after implantation of a small-aperture corneal inlay for the surgical correction of presbyopia: Two-year follow-up.

PURPOSE: To evaluate the change in reading-performance parameters after implantation of the Kamra small-aperture intracorneal inlay over a 2-year follow-up. SETTING: University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. DESIGN: Cohort study. METHODS: This study comprised naturally emmetropic presbyopic patients. Bilateral reading acuity, reading distance, reading speed, and the smallest log-scaled sentence were evaluated in a standardized testing procedure using the Salzburg Reading Desk. The minimum postoperative follow-up was 24 months. RESULTS: The study enrolled 32 patients. The reading desk results showed a significant improvement in each parameter tested. After a mean follow-up of 24.2 months ± 0.8 (SD), the mean reading distance changed from the preoperative value of 48.1 ± 5.5 cm to 38.9 ± 6.3 cm (P < .0001), the mean reading acuity at best distance improved from 0.3 ± 0.14 logRAD to 0.24 ± 0.11 logRAD (P < .000001), and the mean reading speed increased from 142 ± 13 words per minute (wpm) to 149 ± 17 wpm (P=.029). One patient lost 1 line, and 1 patient had no change. The improvement was up to 6 log-scaled lines (mean improvement 2.7 ± 1.6 lines) in the other 30 patients. CONCLUSIONS: After implantation of the small-aperture intracorneal inlay, there was an improvement in all tested reading performance parameters in emmetropic presbyopic patients; the improvement was the result of an increased depth of field. These 2-year results indicate that the inlay is an effective treatment for presbyopia.

Refractive surgical correction of presbyopia with the AcuFocus small aperture corneal inlay: two-year follow-up.

PURPOSE: To evaluate the safety and efficacy of the AcuFocus Corneal Inlay 7000 (ACI 7000) implanted in emmetropic presbyopic patients for the improvement of near and intermediate vision over 2-year follow-up. METHODS: This prospective, non-randomized, non-comparative study included 32 naturally emmetropic presbyopic patients. The intracorneal inlay was implanted in the non-dominant eye over the pupil by creating a superior-hinged flap with the IntraLase 60-kHz femtosecond laser (Abbott Medical Optics). Inlay centration was over the line of sight. Minimum postoperative follow-up was 24 months. RESULTS: After mean follow-up of 24.2±0.8 months (range: 24 to 26 months), 96.9% of patients read J3 or better in the implanted eye. Mean binocular uncorrected near visual acuity improved from J6 preoperatively to J1 after 24 months. Mean binocular uncorrected intermediate visual acuity (UIVA) was 20/20 at 1 month and remained 20/20 throughout 24-month follow-up, with 71.9% of eyes reaching UIVA of 20/20 or better. At 24 months, mean uncorrected distance visual acuity was 20/20 in the implanted eye and 20/16 binocularly. No inlay was explanted during the study. Two decentered inlays were recentered after 6 months because of in-sufficient increase in near and intermediate visual acuity. Both patients' near and intermediate visual acuity improved significantly after recentration. CONCLUSIONS: The ACI 7000 seems to provide a safe and effective treatment for presbyopia over follow-up of 2 years.