In-office procedures offer ophthalmic surgeons and patients the greatest flexibility and efficiency of scheduling. Procedures such as YAG capsulotomy, select laser trabeculoplasty, laser pupil iridoplasty, LASIK/PRK/SMILE and minor lid procedures are routinely done within the in-office surgery suite. A large 2016 study demonstrated the safety and outcomes of cataract procedures performed within the surgeon’s office, and the trend of office-based surgery is expected to grow.^1,2 The opportunity for same-day procedures is appreciated by patients who travel for care, supports the revenue stream for the surgeon and offers minimal down time for the patient to return to normal activities of daily living.

As surgical and therapeutic options for presbyopia expand, in-office presbyopia vision correction and vision therapies present an opportunity for growth. This has been attempted in the past using laser thermal keratoplasty (LTK) and conductive keratoplasty (CK). Unfortunately, effects of vision correction using LTK and CK were unpredictable, with the correction fading over time, leaving patients and surgeons frustrated over the cost/benefit ratio. PresbyLasik was another vision correction option that utilized multifocality to achieve distance and near vision. However, it is not commonly performed due to reduction of distance visual acuity, a side effect of the multifocal ablation profile.³

The newly approved therapeutics utilizing topical miotic therapies for presbyopia will send patients to eye doctors for evaluation, possibly for the first time. Topical miotics may provide short-term benefit for those frustrated with reading glasses and may serve well as a bridge for early presbyopes until they feel comfortable with other surgical options.

What other options are available for in-office presbyopia vision correction? Surgical approaches tend to be lens- or cornea-based procedures that can be performed in either sterile suites or clean suites. Other approaches are emerging that may push the trend to even less intensive environments such as the exam room.

STERILE SUITE PROCEDURES: LENS-BASED PROCEDURES

Refractive lens exchange using a diffractive or extended depth of focus (EDOF) IOL may be performed in the office. Patients familiar with or with a history of keratorefractive surgery may be more likely to proceed with this modality. However, many presbyopes have never had an eye exam; they rely on over-the-counter reading glasses for near tasks and are often unaware of alternative solutions. This group is less likely to elect for an invasive procedure, although more patients are presenting to our offices for solutions. Early presbyopes are a particularly difficult group to manage as invasive procedures are often difficult, especially when distance vision is not an issue.

The EVO Viva ICL Lens (Staar Surgical) may be an option for European presbyopic myopes in the future, though STAAR is not currently pursuing FDA approval for this indication. The monofocal EVO/EVO+ ICL is currently FDA approved for patients aged 20-45 years with -1.0 to -18.0D with astigmatism correction up to 4 D. STAAR received CE Mark approval of the presbyopic indication for its EVO Viva ICL from its European Notified Body, DEKRA, in 2020.⁴ This EDOF phakic lens is implanted bilaterally and does not require peripheral iridoplasty due to its 0.36-mm central hole.

The Care Group India is developing a presbyopic phakic lens with an anterior surface diffractive optic. Implantation found binocular UNVA was 1.0 or better in seven of eight patient (16 eyes). Complications were limited to 2.2% cataract formation, one of which required cataract surgery and one eye with pupillary block glaucoma.⁵

CLEAN SUITE: CORNEAL PROCEDURES

Corneal inlays

Widespread familiarity with corneal surgeries such as LASIK may make corneal inlays more acceptable to early presbyopes. Revision Optics developed the shape-changing Raindrop Near Vision Inlay, but it suffered from high risk of melting and stromal haze. Likewise, the KAMRA pinhole (Acufocus) suffered a high explantation rate due to corneal haze.^6,7

Allographic inlays provide a shape-change alternative similar to the Raindrop with markedly improved biocompatibility. Early investigations using lenticules from SMILE procedures to steepen the central cornea were not associated with corneal haze or keratolysis.⁸ Allotex offers lenticules of acellular cornea sterilized using electron beam radiation. These tissue-additive lenticules are placed under a standard 100- to 120-um femtosecond flap (the prior synthetic inlays required a depth of 250 um). The small volume of transferred tissue carries a smaller antigenic load,⁹ reducing risk of rejection and inflammation. Clinical trials outside the United States are now complete, and Allotex is commercializing the TransForm Corneal Lenticle inlay based on the results of the EU trial.

In this multi-center clinical trial, the non-dominant eye of presbyopic patients, age 41 to 65 with a MRSE of +1.00 D to -0.75 D with ≤0.75 D of refractive cylinder who did not require distance correction but did require +1.75 D to +3.50 D of reading add, were implanted.¹⁰ The trial enrolled 101 presbyopic patients in the EU. Implanted under a standard LASIK flap in a 10-minute procedure, the TransForm Corneal Lenticle has been shown to offer refractive correction of high hyperopia in young patients and presbyopia correction to provide full-range of vision binocularly. Adverse event occurrence was reported to be equivalent to FS-LASIK and SMILE.

The treated hyperopes went up to +8 D with the only issue for extremely high diopter hyperopes being possible epithelial ingrowth due to the thickness of that lenticle. The presbyopes got almost 3 D of extended focus, 98% saw 20/40 near and ~70% saw 20/30 near. Ninety-five percent of the patients were spectacle free at 3 years. No contrast loss has been reported. Though patients typically lose 3-5 letters of distance-corrected vision in the treated eye, no loss of binocular distance vision was reported.

Laser correction

LASIK or SMILE for monovision may be an option for early presbyopes, though both come with the side effect of lost distance vision. Monovision correction may be successful for some, but presbyopia is still progressive. A +1.50-D target will work for 45- to 55-year-old patients, but, as age progresses along with continued effects of presbyopia, patients requiring more reading strength eventually become unhappy. While contact lens monovision correction can be tweaked as patients age, additional surgical correction is difficult, and hyperopic correction does appear to change or fade with time as the native hyperopia or presbyopia progresses.

An incision-free innovation

Clerio Vision is developing a noninvasive laser-induced refractive index correction, or LIRIC, that may be used to address presbyopia. A femtosecond laser is used at 405 nm, levels significantly lower than that used to create a corneal flap or pocket. At this wavelength, the treatment is a 2-photon absorption process that changes the collagen density and alters the refractive index of the corneal tissue in the applied zone.¹¹ This is revolutionary, as other laser procedures change the cornea shape to change the refractive power. Early investigations of this technique were conducted on partially sighted patients using a 3-mm diameter optical zone to create a +2.50 D diffractive bifocal wavefront.¹² An 82-s duration exposure of a 405-nm wavelength fs-laser was used to increase the depth of focus. This treatment is intriguing due to lack of corneal incision and possible reduced risk for dry eye.

CLEAN SUITE: SCLERAL-BASED PROCEDURES

For presbyopes who seek convenience and don’t require refractive vision correction, binocular solutions that provide long lasting benefit, are less invasive and involve minimal pain are the Holy Grail. Refocus Group developed a surgical procedure to reverse presbyopia with the Visibility Micro-Insert System. Using a scleratome, micro inserts are implanted into the four oblique quadrants of the sclera. The micro insert aims to restore zonular tension enabling the focusing muscles to change the shape of the lens.¹³ The Visibility technology showed positive outcomes, but has failed thus far to receive FDA approval.^14,15

The VisioLite Ophthalmic Laser System is a 2.94-um Er:YAG ophthalmic laser being developed by Ace Vision Group. This is an innovative technology designed to perform Laser Scleral Microporation (LSM), a minimally invasive binocular laser therapeutic procedure that aims to recover the eye’s natural biomechanical ability to adjust to various distances, or Dynamic Range of Focus (DRoF). The target of LSM is to address the progressive ocular rigidity correlated with the loss of this function.¹⁶

LSM consists of 47 to 49 micropores with a spot size of 265 um and a depth of 85% of scleral thickness. The micropores are located in a 5-mm x 5-mm diamond matrix in the four oblique quadrants overlying the full length of the ciliary muscles extending from 0.5 mm from the anatomical limbus to the pars plana. These matrices create regions of biomechanical pliability within the sclera over five critical zones of physiological importance.^17,18

The procedure requires approximately 6-8 minutes per eye and can be performed in-office with little to no pain. Ideal candidates are at least 48 years of age with signs of presbyopia without cataracts in otherwise good ocular health.

Early pilot studies being performed OUS show good improvement of DRoF. An average of 78% of patients have binocular DCNVA 20/40 or better at 12 months, and studies are ongoing to evaluate these endpoints at later time points. Patient satisfaction is high for up to 12 months.

LSM is currently not available in the United States.

WELCOME TO THE OFFICE

The future for in-office procedures for the treatment of presbyopia is bright as the next wave of innovation pushes forward, changing surgical ecosystems. New technologies and therapies are emerging that will provide less burden to the physicians and more convenience for their patients. OM

REFERENCES

1. Ianchulev T, Litoff D, Ellinger, D, Stiverson RK, Packer M. Office-based cataract surgery: Population health outcomes study of more than 21 000 cases in the United States. Ophthalmol. 2016;123:723–728.
2. Durrie DS, McCabe C, Whitman J. Office-based surgery vs. ASC surgery. Ophthal Manag. November 2020; 24:34-44. https://www.ophthalmologymanagement.com/issues/2020/november-2020/office-based-surgery-vs-asc-surgery . Accessed July 29, 2020.
3. Shetty R, Brar S, Sharma M, et al. PresbyLASIK: A review of PresbyMAX, Supracor and laser blended vision. Indian J Ophthalmol. December 2020;68:2723-2731. doi: 10.4103/ijo.IJO_32_20.
4. STAAR Surgical Introduces EVO Viva Presbyopia Correcting Lens – See Young Again! https://staar.com/news/2020/staar-surgical-introduces-evo-viva-presbyopia-correcting-lens-see-young-again . Accessed July 16, 2022.
5. R Schmid; H Luedtke. A Novel Concept of Correcting Presbyopia: First Clinical Results with a Phakic Diffractive Intraocular Lens. Clin Ophthalmol. 2020;14:2011-2019. https://doi.org/10.2147/OPTH.S255613 .
6. Paley GL, Harocopos GJ. Histopathologic Analysis of Explanted KAMRA Corneal Inlays Demonstrating Adherent Fibroconnective Tissue Scar Formation. Ocul Oncol Pathol. 2019 Oct;5:440-444. doi: 10.1159/000498944. Epub 2019 Apr 17. PMID: 31768368; PMCID: PMC6873049.
7. Abbouda A, Javaloy J, Alió JL. Confocal microscopy evaluation of the corneal response following AcuFocus KAMRA inlay implantation. J Refract Surg. 2014 Mar;30:172–178.
8. Liu YC, Teo EPW, Ang HP, Seah XY, Lwin NC, Yam GHF, Mehta JS. Biological corneal inlay for presbyopia derived from small incision lenticule extraction (SMILE). Sci Rep. 2018 Jan 30;8:1831. doi: 10.1038/s41598-018-20267-7. PMID: 29382905; PMCID: PMC5789881.
9. Jacob S. Corneal allogenic inlays for presbyopia. Corneal Physician. 2020 Apr; 24:12-15. Accessed 14 July 2022.
10. Allotex clinical trials. https://allotex.com/clinical-trials . Accessed July 16, 2022
11. SM. MacRae. Laser-induced refractive index correction in humans. American Society of Cataract & Refractive Surgery annual meeting, 2019. San Diego. May 6, 2019.
12. Zheleznyak L, Butler SC, Cox IG, et al. First-in-human laser-induced refractive index change (LIRIC) treatment of the cornea. Invest. Ophthalmol. Vis. Sci. 2019;60:5079.
13. Schanzlin D, MD. VisAbility Micro-Insert System for presbyopia. The Pipepine. Millenial Eye. Aug 2016. https://millennialeye.com/articles/2016-jul-aug/visability-micro-insert-system-for-presbyopia/ . Accessed July 18, 2022.
14. Knaus KR, Hipsley A, Blemker SS. The action of ciliary muscle contraction on accommodation of the lens explored with a 3D model. Biomech Model Mechanobiol. 2021;20:879-894. https://doi.org/10.1007/s10237-021-01417-9
15. Hipsley AM, Ma A, Rocha K, Hall B. Laser scleral microporation procedure. Ming Wang, Ed. Surgical Correction of Presbyopia. Slack, Inc. Thorofare, NJ. 2019.
16. Pallikaris IG, Kymionis GD, Ginis HS, Kounis GA, Tsilimbaris MK. Ocular rigidity in living human eyes. Invest Ophthalmol Vis Sci. 2005 Feb;46:409-14. doi: 10.1167/iovs.04-0162. PMID: 15671262.
17. Knaus, K.R., Hipsley, A. & Blemker, S.S. The action of ciliary muscle contraction on accommodation of the lens explored with a 3D model. Biomech Model Mechanobiol. 2021;20:879-894. https://doi.org/10.1007/s10237-021-01417-9
18. Hipsley AM, Ma A, Rocha K, Hall B. Laser Scleral Microporation Procedure. Ming Wang, Ed. Surgical Correction of Presbyopia. Slack, Inc. Thorofare, NJ. 2019.

AnnMarie Hipsley, DPT, PhD, is founder and chief executive officer of Ace Vision Group, Inc., a medical device company pioneering Laser Microporation Therapeutics technologies for the aging eye. She is also the founder of iAware Inc., a non-profit organization for promoting awareness of age-related ocular disease, and cofounder of the International Society of Presbyopia.

Tracy Schroeder Swartz, OD, MS, FAAO, Dipl ABO, earned her Fellowship from the American Academy of Optometry and Diplomate from the American Board of Optometry, concentrating on co-management and anterior segment disease. Financial disclosure: Dr. Swartz is a consultant for Ace Vision Group and Glaukos and a speaker for Allergan.

Sheri Rowen, MD, is a cataract and refractive surgeon at NVision Eye Centers, Newport Beach, Calif. Financial disclosure: Dr. Rowen reports relationships with Aerie, Alcon, Allergan/Abbvie, Bausch + Lomb, J&J Vision, Kala Pharmaceuticals, Novartis, Ocuterra, Orasis, Oyster Point, Tarsus, Trefoil and Zeiss.