Comparison on Outcomes of Four IOLs in Patients With Cataracts

NCT06590272 | Completed

• 1 other identifier: SHSY-LYZX-210
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Intraocular Lens; Visual Outcomes

Outcome Measures

Primary Outcomes (4)

• Postoperative visual acuity

  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.

  3 months

• Postoperative contrast sensitivity

  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.

  3 months

• Postoperative defocus curve

  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.

  3 months

• Postoperative eye-related quality of life

  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.

  3 months after surgery

Study Arms (4)

TECNIS PCB00 IOL (A)

The patients in this groups underwent cataract surgery with TECNIS PCB00 IOL

Device: TECNIS PCB00 intraocular lens

HumanOptics Diff-Aay IOL (B)

The patients in this groups underwent cataract surgery with HumanOptics Diff-Aay IOL

Device: HumanOptics Diff-Aay intraocular lens

TECNIS Symfony ZXR00 IOL (C)

The patients in this groups underwent cataract surgery with TECNIS Symfony ZXR00 IOL

Device: TECNIS Symfony ZXR00 intraocular len

ZEISS AT LISA tri 839MP IOL (D)

The patients in this groups underwent cataract surgery with ZEISS AT LISA tri 839MP IOL

Device: ZEISS AT LISA tri 839MP intraocular len

Interventions

TECNIS PCB00 intraocular lens DEVICE

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

Also known as: IOL

TECNIS PCB00 IOL (A)

HumanOptics Diff-Aay intraocular lens DEVICE

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

Also known as: IOL

HumanOptics Diff-Aay IOL (B)

TECNIS Symfony ZXR00 intraocular len DEVICE

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

Also known as: IOL

TECNIS Symfony ZXR00 IOL (C)

ZEISS AT LISA tri 839MP intraocular len DEVICE

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

Also known as: IOL

ZEISS AT LISA tri 839MP IOL (D)

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cataract ultrasonic emulsification aspiration with one-stage implantation of 4 types of IOLs at the Shanghai Tenth People\'s Hospital from October 2021 to June 2023

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Yiwen Hu

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: August 31, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)