- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04900662
Patient Satisfaction and Visual Function Following Implantation of Trifocals or Extended Range of Vision Intraocular Lenses
2022년 1월 25일 업데이트: Dr. Sherif R El-Defrawy, Queen's University
Patient Satisfaction and Visual Function Following Implantation of Trifocals or Extended
Cataract surgery is a fast evolving refractive procedure, which aims to restore vision.
The majority of intraocular lens (IOL) implants following cataract surgery are monofocal IOLs, which have been designed to improve distance vision by replacing the lens diopter power with a single focal point.
Monofocal IOLs have been associated with very few complications related to the material or the technology.
However, after the surgery patients are spectacle dependent for near and intermediate tasks.
This, in turn, has decreased the patient's post-operative satisfaction and quality of life.
Multifocal intraocular lenses (IOLs) were introduced into the market in the 1980s.
This type of IOLs provides clear distance and near vision, which affects the quality of life and visual expectations of the patients who receive them.
Studies have indicated higher levels of patient's satisfaction with regards to distance and near vision after the implantation of multifocal lenses.
With Multifocal IOLs; however, patients are still spectacle dependent for intermediate tasks such as computer work.
The recent development of trifocal IOLs has been found to provide optimal near, intermediate, and distance visual performances; decrease spectacle dependence; and increase patient satisfaction.AcrySof®IQ PanOptix™ (PanOptix) was introduced into the market in 2015 with a design that allows the IOL to provide optimal near, intermediate, and distance visual performances; decrease spectacle dependence; and increase patient satisfaction.
Despite the benefits of corrected visual acuity at multiple distances, multifocal and/or trifocal IOLs are associated with certain disadvantages, including contrast sensitivity loss, dysphotopsia, halos and glare, which account for over a third of the justifications used for IOL model replacement.
Dysphotopsia is the result of light reflecting off the intraocular lens (IOL) onto the retina which causes a variety of visual symptoms that are expressed in a positive or a negative form.
Positive dysphotopsia refers to bright artifacts that are noticed in only certain lighting conditions, such as glare and halos.
Negative dysphotopsia refers to the formation of a barrier, which prevents light from reaching the retina.
The result of the negative form of dysphotopsia is the formation of shadows that are often in the temporal visual field.
In 2014, the extended range of vision TECNIS Symfony®IOL (Symfony), with new optical technology using a proprietary achromatic diffractive echelette design, received a CE Mark.
However, it was not until 2016 that this IOL became the first extended depth of focus (EDF) IOL to gain approval by the U.S. Food and Drug Administration.
This new optical technology corrects the corneal chromatic aberration for enhanced contrast sensitivity, generating a continuous vision for distance through intermediate into near with low incidence of halos and glare.
Despite the benefits of EDF IOLs, Monaco et al. conducted a study in Italy and indicated that both PanOptix and Symfony IOLs seemed to be good options for patients with intermediate-vision requirements, whereas the PanOptix IOL may be better for patients with near-vision requirements.
A few studies in the literature have evaluated the performance of the PanOptix and Symfony IOLs in Europe.
Our current study would add great value to the literature since to the best of our knowledge; this is the first study to address the same IOLs in North America.
Cataract surgery expectations are continuously rising, and in an effort to maximize patient satisfaction post-operatively, the appropriateness of a patient for a particular IOL implantation should be evaluated carefully during the pre-operative assessment.
Therefore, further research is warranted to evaluate patient satisfaction with both PanOptix and Symfony IOLs.
The purpose of this study is to compare the visual outcomes and the subjective satisfaction results between patients implanted with PanOptix and Symfony IOLs.
연구 개요
상태
모병
정황
연구 유형
관찰
등록 (예상)
480
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5T 3A9
- 모병
- Kensington Eye Institute
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연락하다:
- Mano Chandrakumar
- 전화번호: 6472050493
- 이메일: mchandrakumar@KensingtonHealth.org
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수석 연구원:
- Sherif El-Defrawy, MD/PhD.
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부수사관:
- Matt Schlenker, MD/MSc.
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부수사관:
- Marko Popovic, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
Study population is patients receiving cataract surgery at KEI. Sampling is consecutive.
No limitation based on gender or sex.
설명
Inclusion Criteria:
- any patient receiving cataract surgery at KEI who is able and willing to participate over 18 years old.
Exclusion Criteria:
- less than 18, not receiving cataract surgery at KEI, not able or willing to participate
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
patient burden from preoperative fasting
기간: 2019-2021
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A questionnaire will be used to assess.
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2019-2021
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incidence of aspiration or cancellation of surgery because of preoperative fasting violation
기간: 2019-2021
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A questionnaire will be used to assess.
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2019-2021
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- de Medeiros AL, de Araujo Rolim AG, Motta AFP, Ventura BV, Vilar C, Chaves MAPD, Carricondo PC, Hida WT. Comparison of visual outcomes after bilateral implantation of a diffractive trifocal intraocular lens and blended implantation of an extended depth of focus intraocular lens with a diffractive bifocal intraocular lens. Clin Ophthalmol. 2017 Oct 26;11:1911-1916. doi: 10.2147/OPTH.S145945. eCollection 2017.
- McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
- Calladine D, Evans JR, Shah S, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD003169. doi: 10.1002/14651858.CD003169.pub3.
- Weeber HA, Meijer ST, Piers PA. Extending the range of vision using diffractive intraocular lens technology. J Cataract Refract Surg. 2015 Dec;41(12):2746-54. doi: 10.1016/j.jcrs.2015.07.034.
- Santos BWL, Cançado JEP, Ferraz VAdS, Campos M. Evaluation of life quality of patients submitted to cataract surgery with implants of monofocal, bifocal and multifocal lenses. Revista Brasileira de Oftalmologia 2014;73:86-92
- Gundersen KG, Potvin R. Comparative visual performance with monofocal and multifocal intraocular lenses. Clin Ophthalmol. 2013;7:1979-85. doi: 10.2147/OPTH.S52922. Epub 2013 Oct 7.
- Cochener B, Vryghem J, Rozot P, Lesieur G, Chevalier JP, Henry JM, David T, Lesueur L, Gatinel D, Ganem C, Blanckaert J, Van Acker E, Heireman S, Ghekiere S. Clinical outcomes with a trifocal intraocular lens: a multicenter study. J Refract Surg. 2014 Nov;30(11):762-8. doi: 10.3928/1081597X-20141021-08.
- Attia MS, Auffarth GU, Khoramnia R, Linz K, Kretz FT. Near and intermediate reading performance of a diffractive trifocal intraocular lens using a reading desk. J Cataract Refract Surg. 2015 Dec;41(12):2707-14. doi: 10.1016/j.jcrs.2015.06.038.
- Escandon-Garcia S, Ribeiro FJ, McAlinden C, Queiros A, Gonzalez-Meijome JM. Through-Focus Vision Performance and Light Disturbances of 3 New Intraocular Lenses for Presbyopia Correction. J Ophthalmol. 2018 Jan 31;2018:6165493. doi: 10.1155/2018/6165493. eCollection 2018.
- AcrySof [product information]. Fort Worth TAL, Inc.; 2015
- de Vries NE, Webers CA, Montes-Mico R, Tahzib NG, Cheng YY, de Brabander J, Hendrikse F, Nuijts RM. Long-term follow-up of a multifocal apodized diffractive intraocular lens after cataract surgery. J Cataract Refract Surg. 2008 Sep;34(9):1476-82. doi: 10.1016/j.jcrs.2008.05.030.
- Kinard K, Jarstad A, Olson RJ. Correlation of visual quality with satisfaction and function in a normal cohort of pseudophakic patients. J Cataract Refract Surg. 2013 Apr;39(4):590-7. doi: 10.1016/j.jcrs.2012.11.023. Epub 2013 Feb 6.
- Monaco G, Gari M, Di Censo F, Poscia A, Ruggi G, Scialdone A. Visual performance after bilateral implantation of 2 new presbyopia-correcting intraocular lenses: Trifocal versus extended range of vision. J Cataract Refract Surg. 2017 Jun;43(6):737-747. doi: 10.1016/j.jcrs.2017.03.037.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 7월 5일
기본 완료 (실제)
2021년 8월 31일
연구 완료 (예상)
2023년 12월 31일
연구 등록 날짜
최초 제출
2020년 10월 6일
QC 기준을 충족하는 최초 제출
2021년 5월 21일
처음 게시됨 (실제)
2021년 5월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 2월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 1월 25일
마지막으로 확인됨
2022년 1월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .