Clinical trial NCT04927117: Evaluation of Visual Acuity in Myopic Cataract Patients Using Trifocal Intraocular Lens
Official title: Evaluation of Binocular Visual Acuity in Myopic Cataract Patients Using Trifocal Intraocular Lens : a 2 Years Prospective, Observational, Multi-center Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Myopia
Intraocular Lens
Keywords: Myopia
visual acuity
monocular defocus curve
binocular contrast sensitivity
Lead sponsor: Aier School of Ophthalmology, Central South University
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Myopic Cataract Patients

Brief summary: The PanOptix trifocal IOL is a new trifocal intraocular lens which is proved to provide good range of vision for distance, intermediate and near and good visual quality in cataract patients with normal axial length. But whether it can get the same visual quality in myopia is still unknown

Detailed description: There are a few publications of multi-focal IOLs on Chinese patients with high myopia. From published papers, it is known that performance of multifocal IOLs is satisfied in myopic patients. However there is no publication to investigate PanOptix in moderate and high myopic patients. So it is imperative to demonstrate good performance of PanOptix in those special patients. The purpose of this study is to assess visual performance and patient satisfaction after the implantation of PanOptix in myopic patients.

Eligibility criteria: Inclusion Criteria:

1. Axial myopic patients（Refractive condition match the axial length after eliminate the nuclear cataract induced myopia factor）
2. Corneal astigmatism \<1.0D (IOL-Master 500/700, Carl Zeiss Meditec, Jena, Germany);
3. Eyes with pupil diameter\>2.5 mm (Photopic) and\<6 mm (Mesopic) (Pentacam HR, Oculus Optikgerate GmbH);
4. Eyes with angle kappa\<0.50 mm (Pentacam HR);
5. Eyes with corneal spherical aberration\<0.50 (Pentacam HR)

Exclusion Criteria:

1. Irregular corneal astigmatism
2. Any retinal disease, macular disease(Including myopic MD and retinal diseases) could affect VA, glaucoma and other severe intraocular diseases
3. Moderate-severe dry eye
4. Amblyopia（BCDVA\<0.7 before cataract appears）
5. Patients having difficulties with examinations or 3 months' follow-up.

Primary outcomes:
measure: Axial length (AL)
timeFrame: 1 minute
measure: Uncorrected distance visual acuity
timeFrame: 10 minutes
measure: Uncorrected near visual acuity
timeFrame: 10 minutes
measure: Uncorrected intermediate visual acuity
timeFrame: 10 minutes
measure: contrast sensitivity
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xu Chen
Study officials:
affiliation: Shanghai Aier Eye Hospital China.
name: Xu Chen
role: STUDY_DIRECTOR
References:
citation: Kohnen T, Herzog M, Hemkeppler E, Schonbrunn S, De Lorenzo N, Petermann K, Bohm M. Visual Performance of a Quadrifocal (Trifocal) Intraocular Lens Following Removal of the Crystalline Lens. Am J Ophthalmol. 2017 Dec;184:52-62. doi: 10.1016/j.ajo.2017.09.016. Epub 2017 Sep 18.
citation: Garcia-Perez JL, Gros-Otero J, Sanchez-Ramos C, Blazquez V, Contreras I. Short term visual outcomes of a new trifocal intraocular lens. BMC Ophthalmol. 2017 May 17;17(1):72. doi: 10.1186/s12886-017-0462-y.
citation: Alio JL, Plaza-Puche AB, Alio Del Barrio JL, Amat-Peral P, Ortuno V, Yebana P, Al-Shymali O, Vega-Estrada A. Clinical outcomes with a diffractive trifocal intraocular lens. Eur J Ophthalmol. 2018 Jul;28(4):419-424. doi: 10.1177/1120672118762231. Epub 2018 Apr 5.