Presbyopia Treatment

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Article initiated by:
Frank S. Hwang, MD, Samantha Habhab, MD
All contributors:
Frank S. Hwang, MD, Shruti Aggarwal, MD, Orry Birdsong, M.D., Vandana Reddy, MD
Assigned editor:
Shruti Aggarwal, MD
Review:
Assigned status Up to Date
 by Shruti Aggarwal, MD on September 18, 2024.


Background

Treatment of presbyopia has historically been limited to corrective lenses such as reading glasses, bifocals, multifocals, and contact lenses. Recent advancements in corrective eye surgery have expanded the number of available modalities for presbyopia correction. With more patients valuing freedom from spectacles and contact lenses, safe and effective surgical correction of presbyopia has become increasingly important.

Medical Management

Recently, pilocarpine 1.25% was approved for topical use for presbyopia by the FDA. Clinical studies show an improvement in near and intermediate vision within 15 minutes of instillation lasting for upto 6 hours. Headaches and redness are the reported side effects.[1]

Intraocular procedures for presbyopia correction include intraocular lens implantation with either a multifocal or accommodative lens.[2] Extraocular procedures include corneal inlays and laser refractive surgery, which can be further subdivided into monovision LASIK, presbyLASIK, INTRACOR, and photorefractive keratectomy (PRK).

Lens Based Procedures

See Presbyopia-correcting IOLs

Cornea Based Procedures

Corneal Inlays

Kamra

The most widely studied corneal inlay, the Kamra inlay, was approved by the FDA in April 2015. The Kamra corneal inlay improves near and intermediate vision by way of its small central aperture, placed in the area on or between the pupil center and the corneal vertex, thereby creating a “pinhole effect” and increasing depth-of-focus.[3] The earliest prospective studies on emmetropic presbyopes found significant improvements in UNVA and UIVA after Kamra inlay implantation at one and two-year follow-up.[4][5] UDVA remained unchanged throughout the two year follow up period.[4][6][7]  Kamra inlays have also been shown to be effective in improving functional abilities such as reading performance. Studies looking at long-term improvements in reading performance after Kamra inlay implantation found significant improvements in all reading parameters including: mean reading distance, mean reading acuity, mean reading speed, and smallest print size that could be read.[6][8][9]

Kamra inlays have been shown to be a safe treatment option, with reports of only mild visual disturbances.[10][11] Mean endothelial cell count, central corneal thickness, and contrast sensitivity remained relatively stable throughout a two-year follow up period.[7] Of note, a few studies reported the development of corneal epithelial iron deposits in a half-moon shape along the margin of the inlay, with no demonstrable effect on visual acuity.[3][7][12]

Raindrop

The Raindrop Near Vision inlay was approved by the FDA in June 2016 as a treatment for presbyopia following the results of a large prospective, multi-center FDA clinical trial that demonstrated long-term improvement in near vision with minimal adverse events.[13] The Raindrop inlay differs from the Kamra inlay in that works by reshaping the surface of the cornea, creating an effect much like that of a multifocal lens.[14] In a prospective clinical trial encompassing 373 emmetropic presbyopic eyes implanted with the Raindrop Near Vision inlay, mean binocular UDVA, UIVA and UNVA improved to 20/20 at one year following Raindrop inlay implantatiom.[13]

The Raindrop inlay was thought to have a good safety profile with most studies reporting stable CDVA and CNVA with no eyes losing more than two lines of corrected vision at one year follow-up.[13] [14][15] However, central corneal haze developed in 14% of subjects in the large, multicenter clinical trial and was found to be correlated to more superficial implantation of the inlay.[13] A safety communication from the FDA issued in October 2018 recommended the Raindrop inlay stop being implanted after a post-approval study found 75% of patients experienced corneal haze.

Refractive corneal inlays

The refractive inlays act to change the central refractive index of the cornea, creating a multifocal effect. These include the Flexivue Micro-Lens, the Invue Lens, and the Icolens. The mechanism of action of this inlay lies in its multifocality, with light passing through the central zone of the inlay brought into focus on the retina during far vision, and light passing through the peripheral zone focused onto the retina during near vision. 

While UNVA was found to improve significantly after refractive inlay implantation, two studies using the Icolens and Flexivue lense reported a small, but statistically significant decline in UDVA in the inlay eye. [16][17]

Laser Refractive Surgery

Monovision LASIK

Monovision is a correction strategy that corrects one eye for near vision and the other eye for distance vision (usually the dominant eye). LASIK-induced monovision is overall very effective at bringing about good functional near and far vision. In a retrospective study of 82 myopic presbyopes who underwent monovision LASIK, 95% of patients improved to UNVA of J1 or better in the near eye and 100% of patients achieved UDVA of 20/25 or better in the distance eye.[18]   The induction of micro-monovision--essentially monovision with a lower degree of anisometropia--has been shown to be equally efficacious.[19][20]

While highly efficacious, monovision LASIK involves inducing a degree of anisometropia. With higher degrees of anisometropia comes a loss of stereopsis and contrast sensitivity. A reduction in near and distance stereopsis has been reported in numerous studies on monovision LASIK. [21][22][23]

PresbyLASIK

PresbyLASIK is a multifocal excimer laser approach, which aims to reshape the cornea for both near and far vision in each eye.[24] PresbyLASIK creates an increased depth of field as a way to improve visual acuity for both near and distance.[24] This can be achieved by creating a central hyperpositive area of the eye for near vision, leaving the peripheral cornea for distance vision.[25] This is called central PresbyLASIK. Another approach is peripheral presbyLASIK which shapes the central cornea for distance vision and the peripheral cornea for near vision.[26] Both ablation profiles have been demonstrated to significantly improve both distance and near vision in presbyopes. [25][26]

Both central and peripheral presbyLASIK have been reported to result in a significant decrease in contrast sensitivity at 3, 6, 12, and 18 cycles/degree. [25][26] A small number of patients undergoing peripheral presbyLASIK experienced visual night disturbances with 4.5% reporting glare and 14% reporting night halo.[26] Similar rates of patient-reported visual disturbances are seen in central presbyLASIK. [25]

INTRACOR

INTRACOR is a procedure that traditionally involves placement of 5 intrastromal rings in the center of the visual axis using a femtosecond laser, leading to central corneal steepening, and an  increased depth of focus.[27] [28] [29][30] This procedure is designed primarily for presbyopes and hyperopic presbyopes but is not suitable in myopic presbyopes due to subsequent myopic shift.[31] Multiple studies utilizing INTRACOR with placement of five intrastromal rings demonstrated a significant increase in binocular UNVA. [27] [29][30][31]However, INTRACOR has not been shown to significantly improve mean UDVA, with UDVA remaining relatively stable at follow-up .[29][31][32]

The primary advantage of INTRACOR lies in leaving Bowman’s layer and the epithelium intact, thus reducing risk of infection or intraocular complication.[31] [32]However, this procedure comes at a cost. Loss of CDVA is consistently seen across multiple studies, with patients losing 1-2 lines on average. [27] [28] [29][30] [32][33]Another common complication of INTRACOR is the resultant myopic shift ranging from -0.3 to -0.5 D observed in multiple studies, making it unsuitable for myopes.[27] [28] [29] INTRACOR is not currently FDA approved in the United States.

Photorefractive Keratectomy

Photorefractive keratectomy (PRK) like LASIK is a surgical procedure that uses an excimer laser to reshape the surface of the cornea. However, unlike LASIK, no flap is created. Rather, the central 8.5-9 mm of the corneal epithelium is removed. As a result, PRK comes with a unique set of advantages, including better wound healing and postoperative clarity, and the avoidance of flap-related complications.[34] However, patients must wait for re-epithelialization to occur and there can be a significant amount of postoperative pain.[34][35] Furthermore, other complications such as corneal haze, decreased efficacy in high myopes, reduced visual quality and regression can occur.[36][37] [38]Nevertheless, PRK maintains good outcomes, producing improved visual acuity for both near and far in presbyopic patients. [36]

Sclera Based Procedures

Scleral implants

Scleral implants have been used to increase the area between the ciliary muscle and the sclera to restore accommodation based on Schachar theory. Different types of implants have been used. FDA trials are undergoing for PMMA inserts at approximately 400 microns of depth. Early clinical studies show improvement of near vision but complications such as anterior segment ischemic, scleral perforation and migration of implants remain a concern. [39]

Scleral laser micro-excision

Scleral laser anterior ciliary excision (LaserACE) uses excimer YAG laser to make micro excisions in the sclera at a depth of 90% thickness to increase the plasticity of the scleral tissue during ciliary tissue contraction and improve accommodation. Clinical studies show improved near and intermediate vision. Microperforation of sclera intraoperatively has been reported. In theory LaserACE improves true accommodation and does not alter the cornea or lens as with other treatments. It is under study, long term risks and benefits are unclear and being studied.[40]

References

  1. ↑ https://www.ophthalmologytimes.com/view/fda-approves-eye-drops-for-treatment-of-presbyopia
  2. ↑ Gil-Cazorla R, Shah S, Naroo SA. A review of the surgical options for the correction of presbyopia. Br J Ophthalmol. 2016 Jan;100(1):62-70. doi:10.1136/bjophthalmol-2015-306663.
  3. ↑ 3.0 3.1 Dexl AK, Jell G, Strohmaier C, Seyeddain O, Riha W, Rückl T, Bachernegg A, Grabner G. Long-term outcomes after monocular corneal inlay implantation for the surgical compensation of presbyopia. J Cataract Refract Surg. 2015Mar;41(3):566-75.
  4. ↑ 4.0 4.1 Seyeddain O, Riha W, Hohensinn M, Nix G, Dexl AK, Grabner G. Refractive surgical correction of presbyopia with the AcuFocus small aperture corneal inlay: two-year follow-up. J Refract Surg. 2010 Oct;26(10):707-15.
  5. ↑ Yilmaz OF, Bayraktar S, Agca A, Yilmaz B, McDonald MB, van de Pol C. Intracorneal inlay for the surgical correction of presbyopia. J Cataract Refract Surg. 2008 Nov;34(11):1921-7.
  6. ↑ 6.0 6.1 Dexl AK, Seyeddain O, Riha W, Hohensinn M, Hitzl W, Grabner G. Reading performance after implantation of a small-aperture corneal inlay for the surgical correction of presbyopia: Two-year follow-up. J Cataract Refract Surg. 2011 Mar;37(3):525-31.
  7. ↑ 7.0 7.1 7.2 Seyeddain O, Bachernegg A, Riha W, Rückl T, Reitsamer H, Grabner G, Dexl AK. Femtosecond laser-assisted small-aperture corneal inlay implantation for corneal compensation of presbyopia: two-year follow-up. J Cataract Refract Surg. 2013 Feb;39(2):234-41.
  8. ↑ Dexl AK, Seyeddain O, Riha W, Hohensinn M, Rückl T, Hitzl W, Grabner G. Reading performance after implantation of a modified corneal inlay design for the surgical correction of presbyopia: 1-year follow-up. Am J Ophthalmol. 2012 May;153(5):994-1001.e2.
  9. ↑ Dexl AK, Seyeddain O, Riha W, Rückl T, Bachernegg A, Emesz M, Ruckhofer J, Grabner G. Reading performance and patient satisfaction after corneal inlay implantation for presbyopia correction: two-year follow-up. J Cataract Refract Surg. 2012 Oct;38(10):1808-16.
  10. ↑ Tomita M, Kanamori T, Waring GO 4th, Yukawa S, Yamamoto T, Sekiya K, Tsuru T. Simultaneous corneal inlay implantation and laser in situ keratomileusis for presbyopia in patients with hyperopia, myopia, or emmetropia: six-month results. J Cataract Refract Surg. 2012 Mar;38(3):495-506.
  11. ↑ Tomita M, Kanamori T, Waring GO 4th, Nakamura T, Yukawa S. Small-aperture corneal inlay implantation to treat presbyopia after laser in situ keratomileusis. J Cataract Refract Surg. 2013 Jun;39(6):898-905. doi: 10.1016/j.jcrs.2013.01.034.
  12. ↑ Dexl AK, Ruckhofer J, Riha W, Hohensinn M, Rueckl T, Messmer EM, Grabner G, Seyeddain O. Central and peripheral corneal iron deposits after implantation of a small-aperture corneal inlay for correction of presbyopia. J Refract Surg. 2011 Dec;27(12):876-80.
  13. ↑ 13.0 13.1 13.2 13.3 Whitman J, Dougherty PJ, Parkhurst GD, Olkowski J, Slade SG, Hovanesian J, Chu R, Dishler J, Tran DB, Lehmann R, Carter H, Steinert RF, Koch DD. Treatment of Presbyopia in Emmetropes Using a Shape-Changing Corneal Inlay: One-Year Clinical Outcomes. Ophthalmology. 2016 Mar;123(3):466-75.
  14. ↑ 14.0 14.1 Chayet A, Barragan Garza E. Combined hydrogel inlay and laser in situ keratomileusis to compensate for presbyopia in hyperopic patients: one-year safety and efficacy. J Cataract Refract Surg. 2013 Nov;39(11):1713-21. doi:10.1016/j.jcrs.2013.05.038.
  15. ↑ Garza EB, Chayet A. Safety and efficacy of a hydrogel inlay with laser in situ keratomileusis to improve vision in myopic presbyopic patients: one-year results. J Cataract Refract Surg. 2015 Feb;41(2):306-12.
  16. ↑ Limnopoulou AN, Bouzoukis DI, Kymionis GD, Panagopoulou SI, Plainis S, Pallikaris AI, Feingold V, Pallikaris IG. Visual outcomes and safety of a refractive corneal inlay for presbyopia using femtosecond laser. J Refract Surg. 2013 Jan;29(1):12-8.
  17. ↑ Baily C, Kohnen T, O'Keefe M. Preloaded refractive-addition corneal inlay to compensate for presbyopia implanted using a femtosecond laser: one-year visual outcomes and safety. J Cataract Refract Surg. 2014 Aug;40(8):1341-8.
  18. ↑ Reilly CD, Lee WB, Alvarenga L, Caspar J, Garcia-Ferrer F, Mannis MJ. Surgical monovision and monovision reversal in LASIK. Cornea. 2006 Feb;25(2):136-8.
  19. ↑ Reinstein DZ, Couch DG, Archer TJ. LASIK for hyperopic astigmatism and presbyopia using micro-monovision with the Carl Zeiss Meditec MEL80 platform. J Refract Surg. 2009 Jan;25(1):37-58.
  20. ↑ Reinstein DZ, Carp GI, Archer TJ, Gobbe M. LASIK for presbyopia correction in emmetropic patients using aspheric ablation profiles and a micro-monovision protocol with the Carl Zeiss Meditec MEL 80 and VisuMax. J Refract Surg. 2012 Aug;28(8):531-41.
  21. ↑ Alarcón A, Anera RG, Villa C, Jiménez del Barco L, Gutierrez R. Visual quality after monovision correction by laser in situ keratomileusis in presbyopic patients. J Cataract Refract Surg. 2011 Sep;37(9):1629-35.
  22. ↑ Levinger E, Trivizki O, Pokroy R, Levartovsky S, Sholohov G, Levinger S. Monovision surgery in myopic presbyopes: visual function and satisfaction. Optom Vis Sci. 2013 Oct;90(10):1092-7.
  23. ↑ Garcia-Gonzalez M, Teus MA, Hernandez-Verdejo JL. Visual outcomes of LASIK-induced monovision in myopic patients with presbyopia. Am J Ophthalmol. 2010 Sep;150(3):381-6.
  24. ↑ 24.0 24.1 Pallikaris IG, Panagopoulou SI. PresbyLASIK approach for the correction of presbyopia. Curr Opin Ophthalmol. 2015 Jul;26(4):265-72.
  25. ↑ 25.0 25.1 25.2 25.3 Alio JL, Chaubard JJ, Caliz A, Sala E, Patel S. Correction of presbyopia by technovision central multifocal LASIK (presbyLASIK). J Refract Surg. 2006 May;22(5):453-60.
  26. ↑ 26.0 26.1 26.2 26.3 Pinelli R, Ortiz D, Simonetto A, Bacchi C, Sala E, Alio JL. Correction of presbyopia in hyperopia with a center-distance, paracentral-near technique using the Technolas 217z platform. J Refract Surg. 2008 May;24(5):494-500.
  27. ↑ 27.0 27.1 27.2 27.3 Holzer MP, Mannsfeld A, Ehmer A, et al. Early outcomes of INTRACOR femtosecond laser treatment for presbyopia. J Refract Surg. 2009;25:855–61.
  28. ↑ 28.0 28.1 28.2 Ruiz LA, Cepeda LM, Fuentes VC. Intrastromal correction of presbyopia using a femtosecond laser system. J Refract Surg. 2009;25:847–54.
  29. ↑ 29.0 29.1 29.2 29.3 29.4 Holzer MP, Knorz MC, Tomalla M, et al. Intrastromal femtosecond laser presbyopia correction: 1-year results of a multicenter study. J Refract Surg. 2012;28:182–8.
  30. ↑ 30.0 30.1 30.2 Menassa N, Fitting A, Auffarth GU, et al. Visual outcomes and corneal changes after intrastromal femtosecond laser correction of presbyopia. J Cataract Refract Surg. 2012;38:765–73.
  31. ↑ 31.0 31.1 31.2 31.3 Thomas BC, Fitting A, Khoramnia R, Rabsilber TM, Auffarth GU, Holzer MP. Long-term outcomes of intrastromal femtosecond laser presbyopia correction: 3-year results. Br J Ophthalmol. 2016 Feb 22. pii: bjophthalmol-2015-307672. doi: 10.1136/bjophthalmol-2015-307672.
  32. ↑ 32.0 32.1 32.2 Khoramnia R, Fitting A, Rabsilber TM, Thomas BC, Auffarth GU, Holzer MP. Intrastromal femtosecond laser surgical compensation of presbyopia with six intrastromal ring cuts: 3-year results. Br J Ophthalmol. 2015 Feb;99(2):170-6.doi: 10.1136/bjophthalmol-2014-305642.
  33. ↑ Thomas BC, Fitting A, Auffarth GU, Holzer MP. Femtosecond laser correction of presbyopia (INTRACOR) in emmetropes using a modified pattern. J Refract Surg. 2012 Dec;28(12):872-8.
  34. ↑ 34.0 34.1 Vinciguerra P, Nizzola GM, Nizzola F, Ascari A, Azzolini M, Epstein D. Zonal photorefractive keratectomy for presbyopia. J Refract Surg. 1998 Apr;14(2Suppl):S218-21.
  35. ↑ Torricelli AA, Junior JB, Santhiago MR, Bechara SJ. Surgical management of presbyopia. Clin Ophthalmol. 2012;6:1459-66.
  36. ↑ 36.0 36.1 Artola A, Patel S, Schimchak P, Ayala MJ, Ruiz-Moreno JM, Alio JL. Evidence for delayed presbyopia after photorefractive keratectomy for myopia. Ophthalmology. 2006 May;113(5):735-41.e1.
  37. ↑ Cantu R, Rosales MA, Tepichin E, Curioca A, Montes V, Ramirez-Zavaleta JG. Objective quality of vision in presbyopic and non-presbyopic patients after pseudoaccommodative advanced surface ablation. J Refract Surg. 2005 Sep-Oct;21(5 Suppl):S603-5.
  38. ↑ Felipe AF, Agahan AL, Cham TL, Evangelista RP. Photorefractive keratectomy using a 213 nm wavelength solid-state laser in eyes with previous conductive keratoplasty to treat presbyopia: Early results. J Cataract Refract Surg. 2011 Mar;37(3):518-24.
  39. ↑ Charters L. Refocus Scleral Implants for presbyopia. Ophthalmology Times. http://ophthalmologytimes.modernmedicine.com/ophthalmologytimes/content/tags/barrie-soloway/refocus-scleral-implants-presbyopia. Published 2013
  40. ↑ Hipsley AM, Hall B, Rocha KM. Scleral surgery for the treatment of presbyopia: where are we today? Eye and Vision 2018:volume 5, Article number 4.
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