Skip to main content
Clinical Trials/NCT06590272
NCT06590272
Completed
Not Applicable

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

Shanghai 10th People's Hospital1 site in 1 country103 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Shanghai 10th People's Hospital
Enrollment
103
Locations
1
Primary Endpoint
Postoperative visual acuity
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
June 30, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai 10th People's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Sun Yilin

Resident Physician

Shanghai 10th People's Hospital

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

Outcomes

Primary Outcomes

Postoperative visual acuity

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

Loading locations...

Similar Trials