Results of Scharioth macular lens implant in patients with age-related macular degeneration

Resultado do implante de lente macular Scharioth em pacientes com degeneração macular relacionado a idade

Abstract

Objective:

To describe the outcomes in terms of near visual acuity and quality of life in 10 patients submitted to Scharioth Macular Lens implantation. Setting: João Eugênio Eye Institute, Brasilia, Brazil. Design: Uncontroled clinical trial.

Methods:

Ten pseudophakic patients with DMRI were submitted to the implantation of intraocular SML in the dominant eye in the period of December of 2017 to the March of 2018. All the patients had answered the Low-Vision Quality of Life Questionaire (LVQOLQ) before and after the surgery, with interval of 30 days.

Results:

The results points showed a statistical significant improvement (p<0.001) in the near visual acuity (NVA), without interference in the distance vision. All patients had significant improvements (p<0,05) in LVQOLQ on the item that evaluates the near visual acuity.

Conclusion:

There was an improvement of NVA in all 10 patients, as well as an enhancement to the quality of life in the postoperative period when compared to the preoperative period.

Keywords:
Visual acuity; Quality of life; Cataract; Lens implantation, intraocular; Macular degeneration

Resumo

Objetivo:

Descrever os resultados em termos de acuidade visual para perto e qualidade de vida em 10 pacientes submetidos ao implante de Lentes Maculares Scharioth. Local: Clínica de Olhos João Eugênio, Brasilia, Brasil. Design: Ensaio clínico não controlado.

Métodos:

Dez pacientes pseudofácicos com DMRI foram submetidos ao implante de SML intraocular no olho dominante no período de dezembro de 2017 a março de 2018. Todos os pacientes responderam ao Questionário de Qualidade de Vida em Baixa Visão (LVQOLQ) antes e após a cirurgia, com intervalo de 30 dias.

Resultados:

Os pontos de resultados mostraram uma melhora estatisticamente significativa (p <0,001) na acuidade visual para perto (AVP), sem interferência na visão à distância. Todos os pacientes tiveram melhora significativa (p <0,05) no LVQOLQ no item que avalia a acuidade visual para perto.

Conclusão:

Houve melhora na AVP em todos os 10 pacientes, além de um aumento da qualidade de vida no período pós-operatório quando comparado ao período pré-operatório.

Descritores:
Acuidade visual; Qualidade de vida; Catarata; Implante de lente intraocular; Degeneração macular

Introdction

The age-related macular degeneration (AMD) is a debilitating chronic illness considered one of the most important causes of legal blindness in the world.⁽¹⁾ Image magnification devices have been the main method of assistance to these patients, but the majority of them have the inconvenience of being external and heavy, as magnifying glasses and telelupes.⁽²⁾ Several drawings of intraocular lenses has been tested as an option to help these patients. However, most of them face problems, either of difficult implantation for being large devices, which generates important after-surgical astigmatism, either of the risk of endothelial contact or increase in the incidence of post-operative glaucoma.⁽³⁾

Age-related macular degeneration, as a disease of great impact and high incidence in the elderly population, requires an easily reproducible treatment with a low learning curve.

The Scharioth Macula Lens (SML) is an intraocular hydrophilic acrylic lens with a central button of 1,5 mm and magnification of + 10.0D (Figure 1), it has four haptics of sustentation for positioning in the ridge on pseudophakic eyes4. SML does not affect the peripheral vision and binocularity; it only reduces the reading distance.⁽⁴⁾

Figure 1
Drawing of lens SML

Methods

One well-experienced surgeons performed SML implantation in the dominant eye of ten pseudophakic patients with AMD in the period of December of 2017 to the March of 2018. Written informed consent was obtained from all patients after oral explanation of the purpose and complications of the surgery, and the surgeries were carried under topical anesthesia without occurrences of intraoperative complications.

The inclusion criteria was bilateral presence of AMD with visual acuity in optimum eye better than 1.4 LogMar, for distance visual acuity (DVA), better than 2 letters ETDRS, for near visual acuity (NVA), get visual improvement at 15cm with the use of a +6.00D external lens. In addition, all patients were pseudophakic with monofocal IOL implant at least 6 months prior to SML implantation.

Patients with history of complications, modified intraocular pressure, corneal leukomas or activity of the AMD proved by the OCT were excluded from the study.

All the patients were previously submitted to fluorescein angiography and spectral domain optical coherency tomography (SD-OCT) for evaluation of the stability of the AMD and had answered to the Low-Vision Quality of Life Questionaire (LVQOLQ)⁽⁵⁾ before and after the surgery, with interval of 30 days in the same local of application and orientation of the same technician.

The average age was of 71 years, varying from 64 to 93 years, being 5 females and 5 males. The average prior to surgery intraocular pressure average (IOPa) measured by applanation tonometry was of 16 mmHg varying from 12 to 18 mmHg.

Mean DVA was 1.1 LogMar, varying from 1.4 to 0.9, and the mean NVA was 5 letters ETDRS varying from 3 to 6 letters, and the median LVQOLQ score was 59 points, varying from 48 to 63.

Results

There were no intra or post-operative complications during our analysis. The average intra-ocular pressure after surgery was the same as noticed before, 16 mmHg varying of 12 the 18 mmHg, and none of the patients had complains about worsening of DVA. All patients had a well centered lens at the end of the surgery (Figure 2).

Figure 2
Well centered SML

The results showed a statistical significant improvement (p< 0.05) in the NVA, without interference in the vision for far. The mean postoperative DVA was 1.0 LogMar, ranging from 1.4 to 0.8, while the mean NVA was 15 ETDRS letters ranging from 8 to 18 letters (Graphic 1).

Graph 1
NVA pre visual acuity for near properative ETDRS letters. NVA post: Visual acuity for near postoperative in letters ETDRS.

All patients had improvements in LVQOLQ, the average postoperative score was 74 points. When analyzing only the "Reading and Fine Work" questions of the questionnaire there was significant improvement as well (p< 0,05). Curiously, some patients had also mentioned improvement in some item that evaluate the DVA, specifically in the parts that evaluates the vision in general, appreciation of the images in the television and objects in movement, however it was not possible to measure such fact.

Discussion

Several intraocular devices have already been tested for improvement in visual capacity in patients with AMD. The great advantage of SML over previous devices is that its implantation very similar to any other IOL, consequently, there is almost no learning curve and can be implanted in incisions smaller than 3mm.⁽⁶⁾ Another advantage is not having the risk of developing pupillary blockage, therefore, does not require iridotomy.⁽⁷⁾

Although some authors have related piggyback lenses to be associated with pigmentary dispersion and increased intraocular pressure,⁽⁸⁾ lenses with characteristics proper to implants in the ciliary sulcus have demonstrated a reduction in pigment dispersion.⁽⁹⁾ Moreover, in our sample no patient presented IOP increase postoperatively.

Another advantage of SML is to allow the visualization of the fundus of the eye and, thus, monitoring of the AMD, including with the accomplishment of complementary exams like OCT.⁽¹⁰⁾

Although the SML lens can be placed at the same moment of cataract surgery with an intraocular lens "in the bag", it is important to emphasize the need for a good biometric calculation, because, in order to achieve the best possible result, it is necessary that the patient is close to emmetropy.⁽¹¹⁾ The main contraindications for SML implantation are complicated cataract surgery, with an out-of-capsular lens, zonular dialysis, uveitis, chronic narrow-angle glaucoma, corneal opacification, AMD with active neovascular membrane and patients who do not understand the implant's principles.⁽⁴⁾

Even the SML implant does not interfere with DVA, we observed a qualitative improvement in the responses to LVQOLQ. Theoretically, devices with the principles of the Galileo telescope can promote improvement in vision for distance, but with a reduction in the visual field and visual impairment.⁽¹²⁾ We believe that, in our series, the improvement observed may be related to the degree of satisfaction of the patient, which induces a better psychological state.

In his original work, Scharioth.⁽⁴⁾ reports an expressive improvement in NVA, which is easily explained by the characteristics of SML, however, there was no mention of improvement in DVA, or at least as for the improvement in the quality of life.

The selection of the ideal candidates for the SML implant is another important factor. In our work we followed the recommendation initially described by Scharioth,⁽⁴⁾ and placed as VA cut point from LogMar 1.4 to far, and 2 letters ETDRS with the addition of + 6.00D at 15 cm distance.

This allows to extrapolate the use of SML to other pathologies with low central visual acuity. We recently implanted SML in two patients with Recurrent Macular Hole and in one patient with Diabetic Macular Edema refractory to treatment with intraocular anti-angiogenic, drug delivery devices and vitrectomy. In all cases we obtained significant improvement for near. Although it is not the subject of this study, we believe that the information is relevant.

Conclusion

In summary, there was an improvement in the quality of life and in the NVA in the postoperative period, when compared to the preoperative period. Although SML implantation appears to be a good and safe option for improving NVA in selected patients with AMD, further studies are yet to be done to demonstrate the efficacy of this lens in the long term.

References

• ¹
  Age-Related Macular Degeneration PPP - Updated 2015 [Internet]. San Francisco: Amercian Academy of Ophthalmology; 2015. [cited 2015 Jan 1]. Available from: http://www.aao.org/preferred-practice-pattern/age-related-macular-degeneration-ppp-2015
  » http://www.aao.org/preferred-practice-pattern/age-related-macular-degeneration-ppp-2015
• ²
  Altpeter EK, Nguyen NX. [Requirements for low vision magnification aids in age-related macular degeneration: data from the Tübingen low vision clinic (comparison of 2007-2011 with 1999-2005)]. Ophthalmologe. 2015;112(11):923-8.
• ³
  Singer MA, Amir N, Herro A, Porbandarwalla SS, Pollard J. Improving quality of life in patients with end-stage age-related macular degeneration: focus on miniature ocular implants. Clin Ophthalmol. 2012;6:33-9.
• ⁴
  Scharioth GB. New add-on intraocular lens for patients with age-related macular degeneration. J Cataract Refract Surg. 2015;41(8):1559-63.
• ⁵
  Wolffsohn JS, Cochrane AL. Design of the low vision quality-of-life questionnaire (LVQOL) and measuring the outcome of low-vision rehabilitation. Am J Ophthalmol. 2000; 130(6):793-802.
• ⁶
  Boyd K. What is age-related macular degeneration? [Internet]. San Francisco: Amercian Academy of Ophthalmology; 2016. [cited 2016 Mar 1]. Available from: http://www.aao.org/eye-health/diseases/amd-macular-degeneration
  » http://www.aao.org/eye-health/diseases/amd-macular-degeneration
• ⁷
  Agarwal A, Lipshitz I, Jacob S. Sulcus-implanted mirror telescopic IOL helpful for AMD, other macular disorders [Internet]. Ocular Surgery News U.S.; 2011. [cited 2011 Apr 11]. Available from: http://www.healio.com/ophthalmology/retina-vitreous/news/print/ocular-surgery-news/%7B69de719e-39b7-4c13-b006-fab76a6a24fd%7D/sulcus-implanted-mirror-telescopic-iol-helpful-for-amd-other-macular-disorder
  » http://www.healio.com/ophthalmology/retina-vitreous/news/print/ocular-surgery-news/%7B69de719e-39b7-4c13-b006-fab76a6a24fd%7D/sulcus-implanted-mirror-telescopic-iol-helpful-for-amd-other-macular-disorder
• ⁸
  Chang WH, Werner L, Fry LL, Johnson JT, Kamae K, Mamalis N. Pigmentary dispersion syndrome with a secondary piggyback 3-piece hydrophobic acrylic lens. Case report with clinicopathological correlation. J Cataract Refract Surg. 2007; 33(6):1106-9.
• ⁹
  Kahraman G, Amon M. New supplementary intraocular lens for refractive enhancement in pseudophakic patients. J Cataract Refract Surg. 2010;36(7):1090-4.
• ¹⁰
  Kaskaloglu M, Uretmen O, Yagci A. Medium-term results of implantable miniaturized telescopes in eyes with age-related macular degeneration. J Cataract Refract Surg. 2001;27(11):1751-5.
• ¹¹
  Grzybowski A, Wasinska-Borowiec W, Alio JL, Amat-Peral P, Tabernero J. Intraocular lenses in age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2017;255(9):1687-96.
• ¹²
  Visioncare Ophthalmic Technolgoies. Implantable miniature telescope. Patient information booklet [Internet].[cited 2018 Jul 10]. Available from: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4225b1_06_Patient%20Information%20Brochure%2001%2024%2006.pdf
  » http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4225b1_06_Patient%20Information%20Brochure%2001%2024%2006.pdf

Publication Dates

• Publication in this collection
  13 May 2019
• Date of issue
  Mar-Apr 2019

History

• Received
  18 Dec 2018
• Accepted
  25 Feb 2019