SPS-107 Presbyopia Correction II | ASCRS
2020 ASCRS Virtual Annual Meeting

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Papers in this Session
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Clinical Outcomes of Presbyopia-Correcting Intraocular Lenses in Patients with Fuchs Endothelial Corneal Dystrophy
Authors
Michal Blau- Most, MD
Olga Reitblat, MD, MHA
Ehud I. Assia, MD
Guy Kleinmann, MD
Adi Levy, MHA

Purpose
To report the results of presbyopia-correcting intraocular lenses (IOLs) implantation in patients with Fuchs endothelial corneal dystrophy (FECD).

Methods
A retrospective, case-control study of FECD patients that were implanted with presbyopia-correcting IOLs. The results were compared with a matched group of patients at a case-control ratio of 1:3. Endothelial cell count, uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA), uncorrected near visual acuity (UCNVA) and post-operative refraction were analyzed.

Results
A total of 19 eyes of 10 patients with FECD were included in the study (mean endothelial cell count 1323.52±767.54 cells/mm2). No significant difference between FECD patients and the control group were found in the UCDVA (LogMAR) (mean 0.11±0.13 and 0.06±0.10, P=0.12, respectively), UCIVA (LogMAR) (mean 0.11±0.11 and 0.10±0.12, P=0.98, respectively) and post-operative refraction outcomes (mean spherical equivalent (SE) (D) 0.14±0.31 and -0.21±0.24, P=0.31, respectively).The UCNVA (LogMAR) was better among the FECD patients, 0.03±0.05 compared to 0.15±0.18 in the control group (P=0.009).

Conclusion
Our results suggest that presbyopia-correcting IOLs can be considered in patients with FECD, with clear corneas, that are not candidate for corneal transplantation.
Presbyopia Management Using Drops Binocularly
Author
L. Felipe Vejarano, MD
Purpose
To evaluate the predictability, reproducibility, efficacy, reliability and Safety of this innovative NON-invasive management for Presbyopes.

Methods
Prospective proof of concept of the results in Pseudoaccommodation and Physiologic Accommodation (subjective and objectively (with HD Analyzer, iTracey, OCT, UBM and Scheimpflug)), refraction, visual acuity corrected and uncorrected for far and near distance, refractive change, pupil size and dynamism (Photopic and Scotopic), endothelial cell count, IOP, Keratometry and ACD using the FOV Tears (EyeFocus) binocularly (not MONOVISION).

Results
Pilot Study of 20 patients who received FOV Tears 9; ave 49,65 yo range 41/ 57, the measurements were taken previously, half an hour, 1, 2, 3, 4 and 5 hours later and 1 week and 1 month after. Prospective study of more than 540 patients who are using the drops constantly, the results of their first and second follow-up months later. Globally improve 1 line Far vision and 3 for Near and 1-2 additional lines with continuous use and extraordinary for Intermediate increase 0,75 D in Accommodation Amplitude initially, increasing up to 1,50 D; mild decrease of Pupil Size in Scotopic conditions and no change in Photopic but totally active, mild Myopic shift only in the first hour (-0,12 Diops).

Conclusion
This is a promising, physiologic NON-invasive and adjuvant solution for Presbyopia patients; generating enough independence of glasses for the most activities in the normal life of the patients with no risks neither secondary effects, incredible improve in intermediate vision.
Prevalence of Refractive Lens Exchange in Ophthalmologists Who Perform Refractive Surgery
Authors
Arjan Hura, MD
Guy M. Kezirian, MD

Purpose
To determine the prevalence of refractive lens exchange (RLE) for presbyopia among ophthalmologists who perform refractive surgery and to assess the willingness of these ophthalmologists to recommend RLE to immediate family members.

Methods
A validated 32-question Global Survey on refractive lens exchange in refractive surgeons was sent by e-mail to 500 ophthalmologists randomly selected from two databases. 250 surgeons were chosen from one database of over 2,500 ophthalmologists who had reported outcomes after laser vision correction, and a second database of over 3,800 ophthalmologists who had reported outcomes after premium lens surgery, at some point in the past 10 years. Respondents were excluded from the study if they indicated they were not refractive surgeons or no longer practicing refractive surgery. Responses were solicited by e-mail, with subsequent telephone reminders to non-responders.

Results
Initial results (n = 204) demonstrated that 89% of surveyed surgeons are currently performing RLE. 23% indicated that they would undergo lens replacement for presbyopia correction in the absence of a cataract, 11% reported that they had already undergone a lens procedure for presbyopia, 32% reported that they have recommended RLE to immediate family members, and 19% reported immediate family members have had RLE.

Conclusion
RLE is still perceived as controversial and its prevalence rate among refractive surgeons is unknown. This is the first report to show that ophthalmologists performing refractive surgery are more likely to have RLE themselves, to recommend RLE to family members, and to have family members undergo RLE than the general population.
Global Prevalence, Patient and Economic Burden of Presbyopia: A Systematic Literature Review
Authors
John P. Berdahl, MD
Chandra Bala, MBBS, PhD, FRANZCO
Mukesh Dhariwal, MPH, MBBS
Jessie Lemp-Hull, PhD
Shantanu Jawla, MS

Methods
A systematic search was conducted in the MEDLINE®, Embase®, and Cochrane Library databases from the time of inception through October 2018. Studies published in the English language reporting the epidemiology and patient and economic burden of presbyopia were included. Overall, 64 studies were included for data extraction and reporting.

Results
Global prevalence of presbyopia is predicted to increase from 1.1 billion in 2015 to 1.8 billion by 2050. In 2010, 89% of adults ≥45 years in the United States (US) suffered from presbyopia. Uncorrected presbyopia increases odds of difficulty in performing near-vision tasks and very demanding near-vision tasks by 2-fold and >8-fold respectively. Uncorrected Presbyopia combined with uncorrected distance vision impairment significantly affects patients’ quality of life. Globally, the potential productivity loss due to uncorrected or under-corrected presbyopia in individuals aged <50 years is estimated to be US $11 billion [0.02% of the global Gross Domestic Product].

Conclusion
Presbyopia poses significant burden to societies, and requires timely and optimal correction to minimize impact on vision quality and productivity.
Analysis of Effective Range of Focus after Laser Scleral Microporation in Presbyopic Eyes
Authors
Larissa Gouvea, MD
AnnMarie Hipsley, PhD
Karolinne M. Rocha, MD, PhD, ABO
David H. Ma, MD, PhD
Robert Edward T. Ang, MD
Brad Hall, PhD

Purpose
To evaluate changes in effective range of focus in presbyopic eyes after Laser Scleral Microporation (LSM).

Methods
An Er:YAG laser was used in 4 quadrants on the sclera to improve pliability & biomechanical efficiency of the ciliary muscles in 5 critical zones in 40 eyes of 20 patients. Ray-tracing aberrometer and double-pass wavefront were used to objectively measure visual acuity, higher-order aberrations (HOA), depth of focus (DoF), the visual Strehl ratio based upon the optical transfer function (VSOTF), true accommodation, pseudoaccommodation, and the effective range of focus.

Results
Ray-tracing technology can objectively measure dynamic accommodation as well as specific lens behavior. LSM provided improvement in both accommodative ability and near visual acuity. Early results demonstrate that patients received up to 1D in improvement in true accommodation at 1 month postoperatively. Positive changes after the LSM procedure were also seen in both spherical aberration and DoF. Pseudoaccommodation from changes in spherical aberration and increased depth of focus may contribute to near vision functionality.

Conclusion
Early clinical trial results suggest LSM to be a safe and effective procedure for restoring range of visual performance in presbyopes. Early results also suggest that LSM can improve intermediate and near visual acuity without touching the visual axis. Data collection is ongoing.
Enhanced Depth of Field and Micromonovision with Iol's Versus Laser Vision Correction Versus Trifocal Iol's - 18 Months Follow up (No Audio)
Author
Christoph F. Kranemann, MD

Purpose
To determine the effectiveness and safety of a depth of field with micromonovision approach using either lens implants or corneal refractive surgery versus Trifocal lens implants

Methods
Patients undergoing presbyopia correction were prospectively followed in 3 groups. Group 1 underwent corneal laser refractive surgery with Lasik or SMILE enhancing the depth of field and using micromonovision. Group 2 underwent a refractive lens exchange with a monofocal intraocular lens matching it to the corneal optical zone for a greater depth of field and micromonovision. Group 3 had a refractive lens exchange with a Trifocal intraocular lens. All groups were followed for a minimum of 18 months with refractions/topography/wavefront/corneal endothelial count and monitoring for complications.

Results
A total of 84 patients were enrolled with refractions ranging from -12.0 to +6.0. At month 18 group 1 had a mean uncorrected VA 20/20 distance, 20/20 near and 20/20 intermediate. Group 2 was 20/15 distance, 20/22 near and 20/22 intermediate and Group 3 was 20/20 distance, 20/18 near and 20/22 intermediate. NS Tear osmolality was Group 1 308, Group 2 304 and Group 3 302. Glare and Halos were not statistically significant between groups though Group 1 had more dry eye complaints (P<.01). Group 2&3 had each 3 retinal tears or holes with none in Group 1. No patients had a retinal detachment. The touch up rate was 10% in Group 1 and 5% in Groups 2&3.

Conclusion
All 3 approaches can result in satisfactory outcomes and the approach should be tailored to the individual patient. There is a trend for a higher retinal complication rate in the IOL groups. In the absence of any relevant lens changes, a corneal laser approach might be overall safer.
Restoration of Bionocularity & Visual System Activity after Laser Scleral Microporation
Authors
Olga Rozanova, MD, PhD
Robert Edward T. Ang, MD
AnnMarie Hipsley, PhD
Luca Gualdi, MD
Mitchell A. Jackson, MD, ABO
Brad Hall, PhD

Purpose
To clarify dynamic, self-regulating mechanisms of presbyopia and to evaluate a presbyopic surgical procedure which restores binocularity.

Methods
Patients (n=10) with a range of refractive error without concomitant pathology were examined. The functional state of the visual system in monocular and binocular conditions was investigated using ultrasound biomicroscopy, Schleimpflug imaging, aberrometry, standard ETDRS charts, and pupillometry. Evaluation of the effects of the Laser Scleral Microporation (LSM) procedure on binocularity and stereopsis of 10 patients was also performed.

Results
The decrease of accommodation in presbyopia is accompanied by marked changes in the lens and ciliary muscle, an increase of optical aberrations, changes in diaphragmatic function of the pupil, specific to each of the refractive groups. The shift of image focus zone in presbyopia is accompanied by suppression of binocular cooperation. The degree of binocular summation and stereopsis are reduced. Results from a prospective single arm clinical trial are offered for 10 patients over a 3 month follow up period of presbyopic patients who were treated with the LSM procedure. Stereopsis in these patients improved as well approaching statistical significance at 3 months post operatively.

Conclusion
formation. Unfortunately, most current surgical presbyopia treatments reduce binocular vision, increasing the risk for dissatisfaction post-operatively. An exception is LSM, a treatment which appears not only to restore accommodative function but also binocularity and stereopsis.
Visual Behavior Monitor: Can an Objective Visual Behavior Tool Improve Patient Satisfaction Following Presbyopic IOL Implantation?
Authors
Gerd U. Auffarth, MD, PhD
Suphi Taneri, MD
Pavel Stodulka, MD, PhD

Purpose
To report on the first results of a multi-center, prospective randomized clinical study comparing outcomes following the pre-operative use of the Vivior Visual Behavior Monitor (VBM, Vivior AG, Zurich) to assess patients’ visual needs.

Methods
This European study is a 7-site, prospective, randomized study that is enrolling presbyopia-age and cataract patients who present for treatment. Following informed consent, patients are randomized into one of two arms: 1) Wearing the VBM or, 2) each study site’s standard patient education regarding presbyopic treatment options. The VBM consists of sensors measuring key parameters including distance, ambient light, orientation and motion. The device is attached to the frames of the wearer’s glasses using a magnetic clip. Pre and post-operatively, patients were asked to complete the CatQuest 9 tool, as well as completing an exit interview at the end of the study.

Results
The study will enroll up to 322 patients (644 eyes) at the participating sites in Germany, France, Switzerland and the Czech Republic. As of this submission, patient enrollment has already started. The primary endpoint will be the number of patients choosing an advanced technology intraocular lens (IOL) based on the use of Vivior, as well as the Cat-Q9 score and assessment if the visual outcome matched the patients’ pre-operative expectations.

Conclusion
The VBM is a unique wearable that can objectively track a patient’s lifestyle. This level of data is beneficial to both patient and surgeon, resulting in an individualized treatment solution, which should reduce the likelihood of patient dissatisfaction following cataract surgery and presbyopic treatments.
Visual Behavior: Initial Experience with a Real-Time Objective Measurement Device
Authors
Gerd U. Auffarth, MD, PhD
Ramin Khoramnia, MD
Florian N. Auerbach, MD

Purpose
To understand what insights an objective, visual behaviour monitor can provide clinicians about the visual requirements of patients.

Methods
Clinical and administrative staff of the department of ophthalmology at the University of Heidelberg wore the Visual Behavior Monitor (VBM, Vivior AG, Zurich, Switzerland) for 36 hours over the course of a week. The data was then analysed to identify visual behaviour patterns. The VBM consists of sensors measuring key parameters including distance, ambient light, orientation and motion. The device is attached to the frames of the wearer’s glasses using a magnetic clip.

Results
19 subjects participated in the evaluation with an average age of 41 (Range, 24 to 61). The time spent between distance, intermediate and near visual tasks was almost equally split with an average of 33% of time spent at distance, 35% at intermediate and 32% at near. Subjects were stratified by task into 4 groups, which showed that Group 1 (secretaries, administration staff) spent more than 40% of their time working at near, while Group 2 (technicians, opticians) spent the majority of their time working at intermediate and Group 3 (various professions) worked primarily at distance. Finally, Group 4 (M.D.s) used spent their days working almost equally at the near, intermediate and distance.

Conclusion
Our experience with the VBM provided insight into how different tasks require different visual requirements – highlighting the fact that patients require a more customized approach to visual correction.
Multi-Center Clinical Trial Results of Laser Scleral Microporation in Presbyopic Eyes
Authors
Mitchell A. Jackson, MD, ABO
AnnMarie Hipsley, PhD
David H. Ma, MD, PhD
Robert Edward T. Ang, MD
Sunil Shah, MD, FRCS
Brad Hall, PhD

Purpose
To evaluate changes in visual outcomes in presbyopic eyes after Laser Scleral Microporation (LSM).

Methods
An Er:YAG laser was used in 4 quadrants on the sclera to improve pliability & biomechanical efficiency of the ciliary muscles in 3 critical zones, for 20 patients. Patients were over 40 years of age and showed loss of accommodative ability. Visual outcomes were assessed using the Early Diabetic Retinopathy Study (EDTRS) logMAR charts, randot stereopsis, and intraocular pressure (IOP) was also assessed using a pneumatic tonometer before and after the procedure.

Results
LSM provided improvement in both uncorrected and distance corrected intermediate (UIVA, DCIVA) and near visual acuity (UNVA, DCNVA) with no significant changes to their distance vision. Early results demonstrated that patients receive 5 lines of improvement in their binocular UNVA at 1 month postoperatively, compared to preoperative UNVA. Patients also showed improvement in stereopsis postoperatively.

Conclusion
Early clinical trial results suggest LSM to be a safe and effective procedure for restoring range of visual performance in presbyopes. Early results also suggest that LSM can improve intermediate and near visual acuity without touching the visual axis and without comprising distance vision or stereopsis. Data collection is ongoing.

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