scholarly journals Topical lipoic acid choline ester eye drop for improvement of near visual acuity in subjects with presbyopia: a safety and preliminary efficacy trial

Eye ◽  
2021 ◽  
Author(s):  
Michael S. Korenfeld ◽  
Stella M. Robertson ◽  
Jerry M. Stein ◽  
David G. Evans ◽  
Steven H. Rauchman ◽  
...  

Abstract Objectives This study evaluated the safety of topical lipoic acid choline ester (UNR844, 1.5%) ophthalmic solution and its efficacy in improving distance-corrected near visual acuity (DCNVA) in subjects with presbyopia. Subjects and methods This was a prospective, randomized, double-masked, and multicentre clinical trial. Subjects with a diagnosis of presbyopia (n = 75) were randomized 2:1 to UNR844 or placebo. On days 1–7, all subjects were dosed unilaterally (twice a day, b.i.d.) in their non-dominant eye to ensure safety and tolerability prior to days 8–91 when dosing was changed to bilateral (b.i.d.). Clinical assessments, including DCNVA and adverse events (AEs), were recorded at each study visit. Patients who completed the study were recruited into a non-interventional follow-up study that monitored them until 7 months after their final UNR844 exposure. The primary endpoints were safety and the mean change in DCNVA from baseline in the study eye. Results UNR844 administration (n = 50) produced no safety concerns and was well-tolerated, with no clinically-relevant changes in best-corrected distance visual acuity, pupil size, intraocular pressure, or discontinuations due to adverse events. DCNVA improved in the study eye in the UNR844 group compared to placebo during the 91 days of treatment [UNR844 vs. placebo, mean change in LogMAR (SD); −0.159 (0.120) vs. −0.079 (0.116)]. Bilateral DCNVA improved, with 53.1% UNR844 vs. 21.7% placebo subjects gaining ≥10 letters. Improvements in DCNVA were sustained at 5 and 7 months after UNR844 dosing ceased. Conclusions These results support further development of UNR844 ophthalmic solution for the treatment of presbyopia.

2020 ◽  
Vol 11 (2) ◽  
pp. 448-456
Author(s):  
Andreas F. Borkenstein ◽  
Eva-Maria Borkenstein

Visual impairment resulting from advanced dry age-related macular degeneration (AMD) limits the ability to perform activities required for independent living and adversely affects quality of life. We aimed to determine changes in these parameters in patients with AMD-related geographic atrophy who underwent magnifying cataract surgery (MAGS) using a foldable, bifocal high-add intraocular lens (IOL). The high-add IOL (LENTIS® MAX LS-313 MF 80, Oculentis) was implanted in the better seeing or dominant eye of eligible patients with clinically significant cataract, best corrected distance visual acuity 1.3–0.5 logMAR (20/400–20/63), best corrected near visual acuity >0.8 logMAR (20/125), and stable advanced dry AMD. Self-reported feasibility of performing routine activities and change in quality of life were the main outcome measures. Eleven of 15 operated patients had complete follow-up to 48 months. There were no significant intraoperative or postoperative complications. AMD converted from dry to wet in 2 patients. All patients reported functional gains in the first 3–6 months after surgery, and 10/11 patients reported improved quality of life. From baseline to 48 months, functional performance remained improved in all patients, and quality of life remained improved in the 9 patients with stable AMD. Best corrected distance visual acuity and uncorrected near visual acuity improved in all cases after surgery. Conclusion: Implantation of the high-add IOL was safe and resulted in durable functional and quality of life benefits. To our knowledge, our report describes the longest prospective follow-up (4 years) of a series of patients undergoing MAGS for rehabilitation of low vision related to advanced AMD. Data are needed from larger cohorts, but our experience supports giving consideration to MAGS in appropriately selected patients with low vision related to advanced dry AMD. We encourage further industry development of this technology and additional clinical research to collect more outcomes data to determine its potential to help patients maintain highly valued autonomy and quality of life.


2018 ◽  
Vol 30 (1) ◽  
pp. 139-146 ◽  
Author(s):  
Guilherme Andrade do Nascimento Rocha ◽  
Paulo Ferrara de Almeida Cunha ◽  
Leonardo Torquetti Costa ◽  
Luciene Barbosa de Sousa

Importance: This study shows that a newer long-arc length intrastromal corneal ring segment is efficient and safe for keratoconus treatment. Background: To evaluate visual, tomographic results and complications of a 320-degree intrastromal corneal ring segment implantation with the femtosecond laser for keratoconus treatment. Design: A prospective, nonrandomized, and interventional study. Participants: A total of 34 eyes of 31 patients diagnosed with keratoconus were enrolled. Methods: Patients were divided into two groups based on the strategy used for 320-degree intrastromal corneal ring segment thickness selection. In one group, this selection was based on spherical equivalent (SE group) and in the other on the mean asphericity (Q group). The uncorrected and corrected distance visual acuities, spherical equivalent, K1, K2, Km, Kmax, and mean asphericity ( Q) on corneal tomography were evaluated preoperatively and at 3 and 6 months postoperatively. For astigmatism improvement, we analyzed the corneal tomographic vectorial astigmatism change preoperatively and at 6 months postoperatively. The mean follow-up period was 6.63 ± 0.96 months. Results: The mean uncorrected distance visual acuity and corrected distance visual acuity improved with a significant spherical equivalent improvement ( p < 0.05), with no differences between the 320-degree intrastromal corneal ring segment groups. All corneal tomographic parameters improved significantly ( p < 0.05) between the preoperative and postoperative intervals, with a significant better performance when we used spherical equivalent for the 320-degree intrastromal corneal ring segment thickness selection. Finally, the mean vectorial corneal tomographic astigmatism significantly improved after 6 months, again with no differences between groups. Conclusion: This study suggests that implanting a 320-degree intrastromal corneal ring segment is a safe and effective procedure for treating patients with keratoconus. It also suggests that for thickness selection spherical equivalent is the better strategy.


2020 ◽  
Vol 64 (3) ◽  
pp. 398-404
Author(s):  
Jia Li ◽  
Xu Bai ◽  
Xiaoyue Guan ◽  
Hongfeng Yuan ◽  
Xiang Xu

<b><i>Purpose:</i></b> This study was aimed to investigate the safety and feasibility of umbilical cord-derived mesenchymal stem cell (MSC) transplantation in patients with traumatic optic neuropathy (TON). <b><i>Methods:</i></b> This is a single-center, prospective, open-labeled phase 1 study that enrolled 20 patients with TON. Patients consecutively underwent either optic canal decompression combined with MSC local implantation treatment (group 1) or only optic canal decompression (group 2). Patients were evaluated on the first day, seventh day, first month, third month, and sixth month postoperatively. Adverse events, such as fever, urticarial lesions, nasal infection, and death, were recorded at each visit. The primary outcome was changes in best-corrected visual acuity. The secondary outcomes were changes in color vision, relative afferent pupillary defect, and flash visual evoked potential. <b><i>Results:</i></b> All 20 patients completed the 6-month follow-up. None of them had any systemic or ocular complications. The change in best-corrected visual acuity at follow-up was not significantly different between group 1 and group 2 (<i>p</i> &#x3e; 0.05); however, group 1 showed better visual outcome than group 2. Both groups showed significant improvements in vision compared with the baseline (<i>p</i> &#x3c; 0.05); however, there were no statistically significant differences between the groups (<i>p</i> &#x3e; 0.05). In addition, no adverse events related to local transplantation were observed in the patients. <b><i>Conclusions:</i></b> A single, local MSC transplantation in the optic nerve is safe for patients with TON.


2020 ◽  
pp. 112067212094566
Author(s):  
Michael A Grentzelos ◽  
Nafsika Voulgari ◽  
Clarice Giacuzzo ◽  
Konstantinos Droutsas ◽  
George D Kymionis

Purpose: To report the evolution of corneal flattening after repeated corneal cross-linking (CXL) in a patient with progressive keratoconus during a 6-year follow-up. Methods: Case report. Results: A 27-year-old female underwent CXL for progressive keratoconus. Postoperatively, corneal topography revealed keratoconus progression with an increase of 1.20 diopters (D) in maximum keratometry (Kmax) and CXL was repeated. After the second treatment, a continuing significant corneal flattening (up to 16.00 D in Kmax) was observed during the first 5 years followed by stabilization during the last sixth year of follow-up. Both uncorrected and corrected distance visual acuity were improved while corneal thickness was decreased. There were no complications such as corneal opacification or endothelial cells decrease during the follow-up period. Conclusion: Repeated CXL can induce an excessive corneal flattening more pronounced during the first years of follow-up followed by stabilization thereafter.


2017 ◽  
Vol 2017 ◽  
pp. 1-6
Author(s):  
Daniele Veritti ◽  
Valentina Sarao ◽  
Paolo Lanzetta

Purpose.To evaluate prospectively the safety and efficacy of optimal keratoplasty for the correction of hyperopia and presbyopia.Methods. Consecutive patients undergoing bilateral optimal keratoplasty for refractive presbyopic and hypermetropic corrections were enrolled. Each patient received a complete ophthalmologic examination at baseline, 1 hour, 1 day, 1 week, 1 month, 3 months, and 6 months after treatment.Results. The study included 40 consecutive eyes of 20 patients. All patients reached the 6-month follow-up. No serious intra- or postoperative complications were recorded. Monocular and binocular uncorrected near visual acuities improved significantly during the follow-up (p<0.001). Binocular uncorrected distance visual acuity in presbyopic patients improved from 0.28 logMAR to a maximum of 0.04 logMAR (from 20/38 to 20/22 Snellen equivalent) the day after the treatment and remained significantly better than baseline until the end of the follow-up. A significant improvement of patient satisfaction for near (p<0.001) and distance (p=0.007) activities was seen the day after treatment and was maintained throughout the follow-up.Conclusions.Optimal keratoplasty is a safe, noninvasive, rapid, pain-free, office-based procedure. It offers low to moderate hyperopes and presbyopes an improvement in uncorrected near visual acuity while maintaining or improving their distance visual acuity.


2017 ◽  
Vol 2017 ◽  
pp. 1-7
Author(s):  
Banu Torun Acar ◽  
Suphi Acar

Purpose. To evaluate the effect of cap-lenticule diameter difference (CLDD) on the visual outcome and higher-order aberrations (HOAs) of small-incision lenticule extraction (SMILE). Methods. A total of 132 patients who had bilateral SMILE for myopia or myopic astigmatism were included. The CLDD was 0.4 mm in 54 patients (group 1) and 1.0 mm in 78 patients (group 2). The refractive parameters, uncorrected (UDVA) and corrected distance visual acuity (CDVA), and HOAs were determined preoperatively and during six months follow-up. Results. Group 1 had better CDVA (in logMAR) compared to group 2 at day 1 (−0.07 ± 0.07 versus 0.04 ± 0.07, resp.; p<0.001) and week 1 (−0.07 ± 0.07 versus –0.04 ± 0.07, resp.; p=0.001). The visual acuity improved more in group 1 than in group 2. The UDVA (in logMAR) was 0.07 ± 0.07 and 0.29 ± 0.09 at day 1 (p<0.001) and −0.08 ± 0.07 and −0.06 ± 0.06 at six months (p=0.038) in group 1 and group 2, respectively. Group 1 was associated with significantly less induction of HOAs (0.24 ± 0.08 μm and 0.32 ± 0.26 μm, resp.; p=0.002). Conclusions. In SMILE, 0.4 mm CLDD is associated with better visual outcome and less induction of HOAs than 1.0 mm. Narrow CLDD should be considered in SMILE to increase the visual acuity particularly in the early postoperative period.


2021 ◽  
Vol 8 ◽  
Author(s):  
Ruoyan Wei ◽  
Meiyan Li ◽  
Weiming Yang ◽  
Haipeng Xu ◽  
Joanne Choi ◽  
...  

Purpose: To report the clinical outcomes of phototherapeutic keratectomy (PTK) for pediatric band keratopathy after treatment for retinoblastoma.Methods: A 5-year-old boy presented with a 2-year history of poor visual acuity and a horizontal gray-white band across the central cornea in the right eye. He was diagnosed with band keratopathy after chemo-laser-cryotherapy for retinoblastoma. The band keratopathy was treated via PTK using the Mel-90 excimer laser with an optical treatment zone of 7.0 mm and ablation depth of 120 μm. The patient was followed at 1 week and 3 months postoperatively.Results: Surgery and postoperative follow-up were uneventful. At the 3-month follow-up, the uncorrected distant visual acuity of the right eye improved to 20/125, and the corrected distance visual acuity improved to 20/70 with a refraction of +10.00 D/−2.50 DC × 15. The clarity of the ablated area was evidently improved. The central corneal thickness decreases from 612 to 584 μm. The optical coherence tomography showed the thin band of hyperreflectivity in the ablated area disappeared, corneal transparency improved and the corneal surface smoothened.Conclusions: PTK is a safe and effective procedure to treat band keratopathy following treatment of retinoblastoma in children. Early intervention can reduce the risk of developing deprivation amblyopia.


1970 ◽  
Vol 6 (4) ◽  
pp. 466-471 ◽  
Author(s):  
R Thapa ◽  
MK Shrestha ◽  
R Gurung ◽  
S Ruit ◽  
G Paudyal

Background: Rhegmatogenous retinal detachment is one of the commonly encountered retinal problems where timely treatment could prevent irreversible vision loss. Pneumatic retinopexy (PR) is a simple and minimally invasive procedure for retinal reattachment. Aim: This study aimed to assess the outcome of pneumatic retinopexy in primary rhegmatogenous retinal detachment at our facility. Study design: This was a retrospective- prospective, interventional case series. Materials and methods: All subjects with rhegmatogenous retinal detachment who underwent pneumatic retinopexy at Tilganga Eye Centre of Nepal from January 2002 to June 2007 were included in this study. Results: A total of 32 cases were included in the study. The mean age of patients was 55.2 year (SD=11.0). The majority of cases (62.5%) presented within two weeks of symptoms with blurring of vision in 90% of cases. Pre-operatively, 56.3% (18) patients had a best corrected distance visual acuity of < 6/60. Retinal detachment involving less than two quadrants consisted of 37.5% (12). A single retinal break was present in 78.1% (25) of cases and 87.5% (28) of the retinal breaks were located in the superotemporal quadrant. The macula was attached in 37.5% (12) of the cases. Sulfurhexafluoride and Perfluoropropane were used in 68.8% (22) and 31.3% (10) respectively. The average follow up period was 1.02 years (range one month to four years). The retina was completely attached in 81.3% (26) of cases at the last follow up. The best corrected distance visual acuity of 6/18-6/60 was found in 40.6% (13) of subjects in the last follow up. There was a transient rise in intraocular pressure in 6.3% (2) of subjects after the procedure. Conclusion: The anatomical success rate following pneumatic retinopexy is quite high (81.3%) with good visual recovery and less morbidity translating to higher productivity for the patient. This procedure, being quicker than the alternatives, will also save surgeon's time making PR a good choice for managing primary rhegmatogenous retinal detachment in countries like Nepal where resources are scarce. Key words: Rhegmatogenous retinal detachment, retinal break, pneumatic retinopexy, Nepal   doi: 10.3126/kumj.v6i4.1737   Kathmandu University Medical Journal (2008), Vol. 6, No. 4, Issue 24, 466-471  


Author(s):  
Christoph Leisser ◽  
Manuel Ruiss ◽  
Caroline Pilwachs ◽  
Julius Hienert ◽  
Kristina Stjepanek ◽  
...  

Abstract Background The effect of air tamponade among patients undergoing vitrectomy with membrane peeling for removal of epiretinal membranes (ERM) is controversially discussed. The aim of the present study was to analyze differences in outcomes between air tamponade and balanced salt solution (BSS) in a study population with preoperative intraretinal cystoid changes. Patients and Methods This randomized study included patients scheduled for pars plana vitrectomy with membrane peeling owing to ERM and intraretinal cystoid changes. Air tamponade or BSS at the end of surgery was applied according to preoperative randomization. Optical coherence tomography and best-corrected distance visual acuity (DCVA) measurements were performed before surgery, 5 days after surgery, and 3 months after surgery. Results From 96 patients included, 85 eyes had full follow-up and could be included for analysis. Median improvement of DCVA was + 16 EDTRS letters (IQR: 8 to 22) among patients with BSS, while it was + 13 EDTRS letters (IQR: 8 to 17) among patients with air tamponade. There was a trend for better improvement of DCVA when BSS was left at the end of surgery, compared to air tamponade, but not reaching statistical significance. Conclusions There were no statistically significant differences concerning resorption of preoperative intraretinal cystoid changes, improvement of visual acuity, and final DVCA between air tamponade and BSS.


2021 ◽  
pp. 112067212110528
Author(s):  
Abdelrahman Salman ◽  
Ali Ali ◽  
Shaaban Rafea ◽  
Rana Omran ◽  
Buraa Kubaisi ◽  
...  

Aim To evaluate the long-term outcomes of corneal cross-linking (CXL) in patients with progressive keratoconus. Method In this retrospective non-comparative study, forty-five eyes of 31 patients with progressive keratoconus were treated with 30 min “epi-off” corneal cross-linking. The visual, refractive, topographic and tomographic outcomes were evaluated preoperatively and at least 10 years after cross-linking. Results Ten years post-corneal cross-linking, the mean anterior maximum keratometry decreased (−2.10 ± 3.25 D, P = 0.0001). Conversely, the posterior maximum keratometry increased (6.38 ± 9.79 D, P = 0.065). Both uncorrected and corrected distance visual acuity improved (LogMAR −0.08 ± 0.30) and (LogMAR −0.05 ± 0.21), respectively (P > 0.05, both). A statistically significant hyperopic shift was observed postoperatively (0.70 ± 1.31 D, P = 0.0009). The anterior topographic cylinder values revealed no change (−0.17 ± 1.31 D, P = 0.3), whereas the mean posterior cylinder values decreased (absolute value increased) significantly compared to baseline from −1.31 ± 0.97 D to −1.82 ± 1.78 D, (P < 0.05). The minimum corneal thickness values decreased significantly (−35.11 ± 48.63 µm, P = 0.0001). Four eyes (8.8%) showed more than 1 D increase in the anterior maximum keratometry. Conclusion This protocol and duration of Epi-off corneal cross-linking was found to be effective in halting keratoconus progression over the follow up period (10 years). Anterior corneal flattening and a hyperopic shift were observed. A statistically significant increase in the posterior corneal cylinder was observed. Although, not reaching statistical significance, the logMAR uncorrected and corrected visual acuity were improved.


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