Clinical trial NCT05042856: To Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients
Official title: A Prospective, Single Center Study to Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
High Myopia
Keywords: PanOptix IOL
high myopic cataract patients
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients

Detailed description: A prospective, single center study to evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients.

The objective of this study to investigate the refractive and visual performance of PanOptix and explore their correlation with ELP change, capsular bending formation, IOL tilt/decentration in high myopic cataract patients.

PanOptix IOL provides good refractive outcomes and visual quality because of few ELP change, fast capsular bending formation and few tilt and decentration in high myopic cataract patients.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* 26 ≤Axial length\<30mm, IOL power ≥6D (PanOptix IOL power is available +6D-+30D )
* Eyes with corneal astigmatism less than 1.0D (IOLMaster 700, Carl Zeiss Meditec AG)
* Eyes with pupil diameter between 3 and 5.5 mm (iTrace, Tracey Technology, Houston, Texas, USA)
* Eyes with angle kappa and angle Alpha ≤0.50 mm (iTrace);
* Eyes with corneal spherical aberration ≤ 0.50 (Pentacam).

Exclusion Criteria:

* Irregular corneal astigmatism
* Serious intraoperative complications, glaucoma, pseudoexfoliation syndrome, uveitis, macular degeneration or other retinal impairment
* Moderate-severe dry eye, corneal scarring, amblyopia
* Patients who can't cooperate with post-op 3 months follow-up.

Primary outcomes:
measure: Effective Lens Position（ELP）
timeFrame: 3 months
Secondary outcomes:
measure: capsule bending index（CBI）
timeFrame: 3months
measure: lOL tilt
timeFrame: 3 months
measure: lOL decentration
timeFrame: 3 months
measure: Monocular uncorrected distance visual acuity（UDVA）
timeFrame: 3 months
measure: Monocular best corrected distance visual acuity（BCDVA）(5m)
timeFrame: 3 months
measure: Monocular uncorrected intermediate visual acuity（UIVA）
timeFrame: 3 months
measure: Monocular distance corrected intermediate visual acuity(DCIVA)(60cm)
timeFrame: 3 months
measure: Monocular uncorrected near visual acuity（UNVA）
timeFrame: 3 months
measure: Monocular distance corrected near visual acuity(DCNVA)(40cm)
timeFrame: 3 months
measure: manifest refraction
timeFrame: 3 months
measure: Monocular defocus curve
timeFrame: 3 months
measure: modulation transfer function（MTF）
timeFrame: 3 months
measure: high-order aberrations（HOA）
timeFrame: 3 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Ophthalmology and Optometry Hospital
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: yune zhao, MD
role: STUDY_CHAIR
References: