Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample
Robert Lehmann,1 Andrew Maxwell,2 David M Lubeck,3 Raymond Fong,4 Thomas R Walters,5 Anna Fakadej6 1Lehmann Eye Center, Nacogdoches, TX, USA; 2California Eye Institute, Fresno, CA, USA; 3Arbor Centers for EyeCare, Homewood, IL, USA; 4Manhattan Eye, Ear, and Throat Hospital, Lenox Hill Hospital, New...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Dove Medical Press
2021-04-01
|
| Series: | Clinical Ophthalmology |
| Subjects: | |
| Online Access: | https://www.dovepress.com/effectiveness-and-safety-of-the-clareon-monofocal-intraocular-lens-out-peer-reviewed-fulltext-article-OPTH |
| _version_ | 1818431572128301056 |
|---|---|
| author | Lehmann R Maxwell A Lubeck DM Fong R Walters TR Fakadej A |
| author_facet | Lehmann R Maxwell A Lubeck DM Fong R Walters TR Fakadej A |
| author_sort | Lehmann R |
| collection | DOAJ |
| description | Robert Lehmann,1 Andrew Maxwell,2 David M Lubeck,3 Raymond Fong,4 Thomas R Walters,5 Anna Fakadej6 1Lehmann Eye Center, Nacogdoches, TX, USA; 2California Eye Institute, Fresno, CA, USA; 3Arbor Centers for EyeCare, Homewood, IL, USA; 4Manhattan Eye, Ear, and Throat Hospital, Lenox Hill Hospital, New York, NY, USA; 5Texan Eye, Austin, TX, USA; 6Carolina Eye Associates, PA, Southern Pines, NC, USACorrespondence: Robert LehmannLehmann Eye Center, Nacogdoches, TX, USATel +1 936-569-8278Email doctorlehmann@me.comPurpose: This study assessed effectiveness and safety of the novel Clareon intraocular lens (IOL; model SY60CL; Alcon Vision LLC).Patients and Methods: This was a prospective, single-arm, unmasked clinical trial at 16 investigative clinical sites in the United States. Included were adults ≥ 22 years who required cataract extraction by phacoemulsification. Following phacoemulsification, 350 subjects received SY60CL IOL unilaterally; 342 completed the study. Monocular best corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA) were evaluated. The primary effectiveness endpoint was the percentage of subjects with CDVA ≤ 0.3 logMAR at month 12. Safety was assessed by monitoring adverse events (AEs). Visual acuity and safety outcomes were compared with historical safety and performance endpoint (SPE) rates.Results: At 12 months post-implantation, 99.7% of subjects receiving the SY60CL IOL achieved monocular CDVA ≤ 0.3 logMAR (primary effectiveness endpoint; 1-sided 95% upper confidence limit >SPE rate); 99.7% and 86.8% of subjects achieved monocular CDVA of ≤ 0.34 (20/40 Snellen or better) and ≤ 0.04 logMAR (20/20 Snellen or better), respectively. At 12 months, > 95% of subjects achieved mean monocular UDVA ≤ 0.3 logMAR; 97.1% and 57.6% of subjects achieved monocular CDVA of ≤ 0.34 and ≤ 0.04 logMAR, respectively. Mean monocular CDVA and UDVA were − 0.05 and 0.04 logMAR, respectively. AEs were within SPE limits. The most common nonserious ocular AE was posterior capsule opacification (5.4%). Serious AEs were < 1%, and no serious ocular AEs were assessed as related to the device. There were no observations for IOL glistenings at 12 months.Conclusion: Results of this study supported effectiveness and safety of the SY60CL IOL. Visual acuity outcomes with the SY60CL IOL exceeded the SPE rates for monocular CDVA and AEs were within the limit of historic SPE rates. (Model number SY60WF is the Clareon lens approved by the FDA.)Keywords: glistenings, posterior capsule opacification, visual acuity, cystoid macular edema, dysphotopsia |
| first_indexed | 2024-12-14T15:51:26Z |
| format | Article |
| id | doaj.art-94d7d79311bd400a80e081e21a6274ce |
| institution | Directory Open Access Journal |
| issn | 1177-5483 |
| language | English |
| last_indexed | 2024-12-14T15:51:26Z |
| publishDate | 2021-04-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Ophthalmology |
| spelling | doaj.art-94d7d79311bd400a80e081e21a6274ce2022-12-21T22:55:23ZengDove Medical PressClinical Ophthalmology1177-54832021-04-01Volume 151647165764079Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large SampleLehmann RMaxwell ALubeck DMFong RWalters TRFakadej ARobert Lehmann,1 Andrew Maxwell,2 David M Lubeck,3 Raymond Fong,4 Thomas R Walters,5 Anna Fakadej6 1Lehmann Eye Center, Nacogdoches, TX, USA; 2California Eye Institute, Fresno, CA, USA; 3Arbor Centers for EyeCare, Homewood, IL, USA; 4Manhattan Eye, Ear, and Throat Hospital, Lenox Hill Hospital, New York, NY, USA; 5Texan Eye, Austin, TX, USA; 6Carolina Eye Associates, PA, Southern Pines, NC, USACorrespondence: Robert LehmannLehmann Eye Center, Nacogdoches, TX, USATel +1 936-569-8278Email doctorlehmann@me.comPurpose: This study assessed effectiveness and safety of the novel Clareon intraocular lens (IOL; model SY60CL; Alcon Vision LLC).Patients and Methods: This was a prospective, single-arm, unmasked clinical trial at 16 investigative clinical sites in the United States. Included were adults ≥ 22 years who required cataract extraction by phacoemulsification. Following phacoemulsification, 350 subjects received SY60CL IOL unilaterally; 342 completed the study. Monocular best corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA) were evaluated. The primary effectiveness endpoint was the percentage of subjects with CDVA ≤ 0.3 logMAR at month 12. Safety was assessed by monitoring adverse events (AEs). Visual acuity and safety outcomes were compared with historical safety and performance endpoint (SPE) rates.Results: At 12 months post-implantation, 99.7% of subjects receiving the SY60CL IOL achieved monocular CDVA ≤ 0.3 logMAR (primary effectiveness endpoint; 1-sided 95% upper confidence limit >SPE rate); 99.7% and 86.8% of subjects achieved monocular CDVA of ≤ 0.34 (20/40 Snellen or better) and ≤ 0.04 logMAR (20/20 Snellen or better), respectively. At 12 months, > 95% of subjects achieved mean monocular UDVA ≤ 0.3 logMAR; 97.1% and 57.6% of subjects achieved monocular CDVA of ≤ 0.34 and ≤ 0.04 logMAR, respectively. Mean monocular CDVA and UDVA were − 0.05 and 0.04 logMAR, respectively. AEs were within SPE limits. The most common nonserious ocular AE was posterior capsule opacification (5.4%). Serious AEs were < 1%, and no serious ocular AEs were assessed as related to the device. There were no observations for IOL glistenings at 12 months.Conclusion: Results of this study supported effectiveness and safety of the SY60CL IOL. Visual acuity outcomes with the SY60CL IOL exceeded the SPE rates for monocular CDVA and AEs were within the limit of historic SPE rates. (Model number SY60WF is the Clareon lens approved by the FDA.)Keywords: glistenings, posterior capsule opacification, visual acuity, cystoid macular edema, dysphotopsiahttps://www.dovepress.com/effectiveness-and-safety-of-the-clareon-monofocal-intraocular-lens-out-peer-reviewed-fulltext-article-OPTHglisteningsposterior capsule opacificationvisual acuitycystoid macular edemadysphotopsia |
| spellingShingle | Lehmann R Maxwell A Lubeck DM Fong R Walters TR Fakadej A Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample Clinical Ophthalmology glistenings posterior capsule opacification visual acuity cystoid macular edema dysphotopsia |
| title | Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample |
| title_full | Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample |
| title_fullStr | Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample |
| title_full_unstemmed | Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample |
| title_short | Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample |
| title_sort | effectiveness and safety of the clareon monofocal intraocular lens outcomes from a 12 month single arm clinical study in a large sample |
| topic | glistenings posterior capsule opacification visual acuity cystoid macular edema dysphotopsia |
| url | https://www.dovepress.com/effectiveness-and-safety-of-the-clareon-monofocal-intraocular-lens-out-peer-reviewed-fulltext-article-OPTH |
| work_keys_str_mv | AT lehmannr effectivenessandsafetyoftheclareonmonofocalintraocularlensoutcomesfroma12monthsinglearmclinicalstudyinalargesample AT maxwella effectivenessandsafetyoftheclareonmonofocalintraocularlensoutcomesfroma12monthsinglearmclinicalstudyinalargesample AT lubeckdm effectivenessandsafetyoftheclareonmonofocalintraocularlensoutcomesfroma12monthsinglearmclinicalstudyinalargesample AT fongr effectivenessandsafetyoftheclareonmonofocalintraocularlensoutcomesfroma12monthsinglearmclinicalstudyinalargesample AT walterstr effectivenessandsafetyoftheclareonmonofocalintraocularlensoutcomesfroma12monthsinglearmclinicalstudyinalargesample AT fakadeja effectivenessandsafetyoftheclareonmonofocalintraocularlensoutcomesfroma12monthsinglearmclinicalstudyinalargesample |