Published in Research

Ace Vision Group to present nine new sets of scientific data focused on laser scleral microporation at the ESCRS annual meeting

Ace Vision Group, Inc., (AVG) an emerging ophthalmic device company focused on bringing innovative touchless lasers to patients suffering from age-related vision loss and eye diseases, announced it will present nine sets of research on the effectiveness of Laser Scleral Microporation (LSM) at the annual congress of the European Society of Cataract and Refractive Surgeons.

The global prevalence of presbyopia is expected to peak at approximately 2.1 billion by 2030.1 LSM is an ultra-minimally invasive procedure with a novel therapeutic approach to treating the aging eye. Surgeons can help patients with presbyopia by restoring the age-related loss of Dynamic Range of Focus (DRoF) with Laser Scleral Microporation (LSM) is a therapy applied outside the visual axis to achieve eye rejuvenation. An automated touchless Er: Yag laser creates tiny micropores in the sclera, uncrosslinking collagen and elastin fibrils, creating areas of biomechanical pliability. The treatment restores near and intermediate visual acuity without affecting distance visual acuity.

“We are thrilled to share the scientific research supporting the development and efficacy of the LSM procedure to help address the global prevalence and significance of progressive presbyopia,” said AnnMarie Hipsley, DPT, Ph.D., Founder and CEO of AVG. “Improving the Dynamic Range of Focus (DRoF) for clear through focus vision at variable distances can enormously impact quality of life.” Said Dr. Mitch Jackson, MD, Global Medical Director of Ace Vision Group. “Ace Vision is excited about bringing a therapeutic laser solution for presbyopia that does not touch the visual axis and reduces age-related ocular rigidity, restoring the natural ability of the eye to change focus again dynamically.”

Robust clinical research from AVG will include:

Dynamic Range of Focus Recovery in Emmetropic Presbyopes after Laser Scleral Microporation:  24 Month Pilot Study Outcomes - Ang, Robert et al. The purpose of this study is to evaluate Dynamic Range of Focus (DRoF) after bilateral Laser Scleral Microporation (LSM) in presbyopic eyes. Visual acuity data collected from 100 eyes of 50 participants demonstrated that LSM improved vision such that reading spectacles are generally unnecessary sustained over data collection period of 24 months. “There is an urgent need for a safe and effective treatment that is not affecting the patient’s normal vision,” said Robert T. Ang, MD who was the Principal Investigator for the LSM IRB Registered Study in Makati City Philippines. Dr. Ang said regarding the 100 eyes of 50 patients who received the LSM therapy, “After almost two years of follow-up our patients are very happy and although they all respond differently, they are not using glasses for their normal daily activities.”

Evaluation of the Correlation of Depth and Visual Acuity After Laser Scleral Microporation in Presbyopic Eyes Utilizing AS-SS OCT - Gualdi, Luca et al.This retrospective study determined the accuracy of real-time optical coherence tomography (OCT) guided LSM and evaluated the effects of depth on the efficacy of Dynamic Range of Focus (DRoF) after LSM. Anterior segment swept-source OCT (ASS-OCT) measurements and automatic tissue segmentation (ATS) image processing were utilized as an optimization planning tool for the efficacy of the LSM procedure to verify and optimize the target depth, pore volume fraction, and total treatment.Rejuvenation of Visual Age Utilizing a Novel Microporation Therapy to Uncrosslink the Sclera - Yeu Elizabeth et al.This study evaluated the loss of Dynamic Range of Focus (DRoF) as a function of visual age and the potential for Laser Scleral Microporation(LSM) to rejuvenate visual age in presbyopic eyes. The authors correlated the relationship between the DCNVA of presbyopic subjects, published expected DCNVA by age, and a proprietary formula to calculate "visual age" to determine the effects of uncrosslinking ocular rigidity using LSM.iii Results of 100 eyes of 50 patients showed a sustained visual age for 12 months of 15.4 years. "After LSM, eyes were immediately 18.7 years younger in terms of "visual age," and after one year, eyes were still over 15 years younger than at baseline," reported Elizabeth Yeu, MD. "Our findings showed that LSM does provide sustained rejuvenation, demonstrating that age-related vision loss due to presbyopia is recoverable."

Prevalence and Impact of Vision Impairment of Uncorrected Presbyopia - Hipsley, AnnMarie. This interdisciplinary call to action is to revise the classification of presbyopia from a normal irreversible aging process with a responsive health promotion model of Ocular Health, Fitness and Prevention through awareness. This presentation covered a literature review as a collative report of published evidence on the burden of uncorrected presbyopia concerning prevalence and the socioeconomic impact on patient quality of life and Gross Domestic Product (GDP). Key Strategies for Presbyopia Health Promotion and Awareness with specific reference to a plan of action for reducing ocular pathologies associated with presbyopia included recognizing the onset of presbyopia as a gateway to age-related ocular diseases and sight loss. 

The study revealed 1.8 billion people globally with presbyopia in 2022, 826 million of whom had near visual impairment and significantly reduced quality of life due to uncorrected presbyopia. Global unmet need for presbyopia correction in 2022 is estimated to be 42.9%.2

"The global prevalence of presbyopia represents a large unmet need due to lack of accessibility to ophthalmology services as well as the lack of interdisciplinary education, awareness, and educational constructs," said Dr. AnnMarie Hipsley. "The pathophysiological effects of the progressive loss of Dynamic Range of Focus (DRoF) function on ocular health & longevity need to be identified and understood by the ophthalmic community." Dr. Hipsley stressed, "There is an urgent need for Global Health Promotion and Awareness for Ocular Health & Fitness."

Further presentations include:

  • Therapeutic Approaches Addressing Loss of DRoF in Presbyopic Patients. Jackson, Mitch et al.
  • Virtual Clinical Trial Using A 3D Virtual Eye Simulation Analyzer to Predict Effectiveness of Laser Scleral Microporation for Progressive Presbyopia. Hipsley, AnnMarie et al.
  • Clinical Strategies for Successful Evaluation​ of the Presbyopic Patient. Katz, James A et al.
  • Evaluating A Dose Algorithm for Laser Scleral Microporation (LSM) Therapy for Progressive Presbyopia Using A 3D Finite Element Predictive Model. Sabatier, Laurent et al.
  • Patient Reported Outcomes Assessed Using the Near Activity Visual Questionnaire of Presbyopic Subjects after Laser Scleral Microporation. Ang, Robert et all

The schedule of the September 8-12 ESCRS meeting in Vienna can be viewed in the online program.


References
1. Katz, J. Et al. Presbyopia – A Review of Current Treatment Options and Emerging Therapies. Clin Ophthalmol. 2021; 15: 2167–2178. Published online 2021 May 24. doi: 10.2147/OPTH.S259011
2. Berdahl, J., Bala, C., Dhariwal, M., Lemp-Hull, J., Thakker, D., & Jawla, S. (2020). Patient and Economic Burden of Presbyopia: A Systematic Literature Review. Clinical ophthalmology (Auckland, N.Z.), 14, 3439–3450. https://doi.org/10.2147/OPTH.S269597iii Tarrant J, Thomas E, Tsai L, Kasthurirangan S. Evaluation of devocus curve performance with two visual acuity testing systems: ETDRS and FrACT IOVS 2015; 56:3891.