Clinical trial NCT06590272: Comparison on Outcomes of Four IOLs in Patients With Cataracts
Official title: Comparison on Visual and Refractive Outcomes of Four Different Types of IOL in Patients With Cataracts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Intraocular Lens
Visual Outcomes
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 103
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cataract ultrasonic emulsification aspiration with one-stage implantation of 4 types of IOLs at the Shanghai Tenth People\&#39;s Hospital from October 2021 to June 2023

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative visual acuity
timeFrame: 3 months
measure: Postoperative contrast sensitivity
timeFrame: 3 months
measure: Postoperative defocus curve
timeFrame: 3 months
measure: Postoperative eye-related quality of life
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10th People&#39;s Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People&#39;s Hospital
name: Yiwen Hu
role: PRINCIPAL_INVESTIGATOR
References: