To Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients

Wenzhou Medical University20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataract High Myopia

Interventions

PanOptix IOL implantationPROCEDURE

All the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, China

Outcomes

Primary Outcomes

Effective Lens Position（ELP）

Mean change of ELP for 3 months

Time frame: 3 months

Secondary Outcomes

capsule bending index（CBI）

Post-op 1 day，1week，1month，and 3 months monocular CBI(Swept source OCT,Casia SS-1000; Tomey)

Time frame: 3months

lOL tilt

Post-op 1 day ,1 week,1 month and 3 months lOL tilt(Swept source OCT,Casia SS-1000; Tomey)

Time frame: 3 months

lOL decentration

Post-op 1 day ,1 week,1 month and 3 months lOL decentration(Swept source OCT,Casia SS-1000; Tomey)

Time frame: 3 months

Monocular uncorrected distance visual acuity（UDVA）

Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular UDVA(Chinese standard logarithmic charts)

Time frame: 3 months

Monocular best corrected distance visual acuity（BCDVA）(5m)

Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular BCDVA(5m)(Chinese standard logarithmic charts)

Time frame: 3 months

Monocular uncorrected intermediate visual acuity（UIVA）

Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular UIVA(Chinese standard logarithmic charts)

Time frame: 3 months

Monocular distance corrected intermediate visual acuity(DCIVA)(60cm)

Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular DCIVA(60cm)(Chinese standard logarithmic charts)

Central Contacts

yinying zhao

CONTACT

+86 13957763247 ginger146@126.com

Data from ClinicalTrials.gov

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