Comparison on Outcomes of Four IOLs in Patients With Cataracts

Completed

• Conditions: Cataract; Intraocular Lens; Visual Outcomes
• Interventions: Device: TECNIS PCB00 intraocular lens; Device: HumanOptics Diff-Aay intraocular lens; Device: TECNIS Symfony ZXR00 intraocular len; Device: ZEISS AT LISA tri 839MP intraocular len

• Registration Number: NCT06590272
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Study First Submitted: 2024-08-31
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-05
• Last Update Submitted: 2024-09-05
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TECNIS PCB00 IOL (A)	TECNIS PCB00 intraocular lens	The patients in this groups underwent cataract surgery with TECNIS PCB00 IOL
HumanOptics Diff-Aay IOL (B)	HumanOptics Diff-Aay intraocular lens	The patients in this groups underwent cataract surgery with HumanOptics Diff-Aay IOL
TECNIS Symfony ZXR00 IOL (C)	TECNIS Symfony ZXR00 intraocular len	The patients in this groups underwent cataract surgery with TECNIS Symfony ZXR00 IOL
ZEISS AT LISA tri 839MP IOL (D)	ZEISS AT LISA tri 839MP intraocular len	The patients in this groups underwent cataract surgery with ZEISS AT LISA tri 839MP IOL

Primary Outcome Measures

Name	Time	Method
Postoperative visual acuity	3 months	The 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 sensitivity	3 months	The 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 curve	3 months	Defocus 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 life	3 months after surgery	Based 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.

Trial Locations

Locations (1)

Shanghai 10th People's Hospital; 🇨🇳 Shanghai, Shanghai, China