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Completed

NCT Number: NCT06590272

Comparison on Outcomes of Four IOLs in Patients With Cataracts

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.

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Key information

Conditions

Cataract Eye Diseases Intraocular Lens Lens Diseases Visual Outcomes

Age range

50 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TECNIS PCB00 intraocular lens

Device

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

Other names: IOL

HumanOptics Diff-Aay intraocular lens

Device

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

Other names: IOL

TECNIS Symfony ZXR00 intraocular len

Device

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

Other names: IOL

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

Other names: IOL

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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