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Comparison on Outcomes of Four IOLs in Patients With Cataracts

Comparison on Visual and Refractive Outcomes of Four Different Types of IOL in Patients With Cataracts

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06590272
Enrollment
103
Registered
2024-09-19
Start date
2021-10-01
Completion date
2023-06-30
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Intraocular Lens, Visual Outcomes

Brief summary

The objective of this study was to compare the objective visual outcomes and subjective fuctional vision of four different intraocular lens (IOL) in patients underwent cataracts surgery. This was a retrospective study. Patients with age-related cataract underwent phacoemulsification combined with IOLs implantation. Patients were divided into 4 groups. Uncorrected distant visual acuity(UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA),and the best corrected visual acuity (BCVA) 1 month and 3 months after the surgery were determined. The defocus curve, contrast sensitivity, and customized VF-14-oriented Visual Function Index questionnaire were performed 3 months postoperatively. Kruskal-Wallis test and generalized estimating equation(GEE) were used to analyze and compare the difference between objective visual outcomes and subjective visual quality among different groups.

Detailed description

The objective of this study was to compare the objective visual outcomes and subjective fuctional vision of four different intraocular lens (IOL) in patients underwent cataracts surgery. This was a retrospective study. Patients with age-related cataract underwent phacoemulsification combined with IOLs implantation. Patients were divided into group A (TECNIS PCB00 IOL), Group B (HumanOptics Diff-Aay IOL), Group C (TECNIS Symfony ZXR00 IOL) and group D (ZEISS AT LISA tri 839MP IOL). Uncorrected distant visual acuity(UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA),and the best corrected visual acuity (BCVA) 1 month and 3 months after the surgery were determined. The defocus curve, contrast sensitivity, and customized VF-14-oriented Visual Function Index questionnaire were performed 3 months postoperatively. Kruskal-Wallis test and generalized estimating equation(GEE) were used to analyze and compare the difference between objective visual outcomes and subjective visual quality among different groups.

Interventions

DEVICETECNIS PCB00 intraocular lens

In this study, we select TECNIS PCB00 IOL for inserting in the eyes during the cataract surgery

DEVICEHumanOptics Diff-Aay intraocular lens

In this study, we select HumanOptics Diff-Aay IOL for inserting in the eyes during the cataract surgery

DEVICETECNIS Symfony ZXR00 intraocular len

In this study, we select TECNIS Symfony ZXR00 IOL for inserting in the eyes during the cataract surgery

DEVICEZEISS AT LISA tri 839MP intraocular len

In this study, we select ZEISS AT LISA tri 839MP IOL for inserting in the eyes during the cataract surgery

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

* age-related cataract with myopia≤-6.0D and over 0.0D * axial length≤26mm and corneal astigmatism≤1.5D * well-cooperation of finishing preoperative examinations * completion of all follow-up visits

Exclusion criteria

* previous eye diseases that affect vision including keratopathy, glaucoma, uveitis, amblyopia, fundus diseases, etc. * patients with decreased cognitive ability, unable to cooperate with preoperative examination, or suffering from severe anxiety, depression and mental illness * serious complications during operation, including corneal injury, iris injury, expelling choroidal hemorrhage, posterior capsule rupture, etc * serious postoperative complications, including displacement of intraocular lens, macular edema, endophthalmitis, etc * follow-ups less than 3months

Design outcomes

Primary

MeasureTime frameDescription
Postoperative visual acuity3 monthsThe uncorrected distant visual acuity(UDVA), the best corrected distant visual acuity (BCVA) (5 m), the uncorrected intermediate visual acuity(UIVA) (80 cm) and the uncorrected near visual acuity(UIVA) (40 cm) were chosen as the index to evaluate the VA. The UDVA and BCVA were examined by logarithmic visual acuity chart. The UIVA and UIVA were examined by using a near eye chart.They were all measured 1 month and 3 months after the surgery.
Postoperative contrast sensitivity3 monthsThe contrast sensitivity was used to conduct the assessment by CSV-1000E (VectorVision, USA) under photopic (85 cd/m2) condition at a 2.5m distance. The logarithmic values for 3, 6, 12, and 18 cycles/degree (c/d) were analyzed 3 months postoperatively.
Postoperative defocus curve3 monthsDefocus curve was used to evaluate the visual quality of functional intraocular lens after surgery. The insertion range was -4.0 D \ + 2.0 D, increasing by 0.5 D. The best corrected distant visual acuity was recorded at each diopter 3 months postoperatively.
Postoperative eye-related quality of life3 months after surgeryBased on the American Questionnaire on Visual Function Index-14 (VF-14), the Chinese-oriented version(VF-12-CN) was used to investigate the postoperative near-vision, visual satisfaction, ocular discomfort, visual disturbance, and subjective feelings of far-vision, middle-vision and near-vision. Each question was divided into 4 levels and the scores ranked from 0 to 3 points. Considering the visual interference such as glare and halo, the evaluation of glare and halo visual interference phenomenon was also added.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026