Comparing Monofocal IOLs in Highly Myopic Cataract Patients

Comparison of the Clinical Outcomes of Extended Depth of Focus Intraocular Lenses and Monofocal Intraocular Lenses in Patients With High Myopia Undergoing Cataract Surgery.

Comparison of Postoperative Outcomes in Patients with High Myopia Undergoing Cataract Surgery Implanted with Extended Depth of Focus Intraocular Lens (ICB00) and Monofocal Intraocular Lens (ZCB00)

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract
• Intervention / Treatment: Other: no intervention

Detailed Description

In this study, we aim to compare the visual outcomes and quality of life between highly myopic patients with cataracts who receive implantation of extended depth of focus (EDOF) intraocular lenses (ICB00) and monofocal intraocular lenses (ZCB00). This is a case-control study, planning to recruit 64 highly myopic patients with cataracts, aged between 40 and 70, with 32 in each group. The primary endpoints of the study are the best-corrected visual acuity (BCVA) and defocus curve at 6 months postoperatively. Secondary endpoints include uncorrected visual acuity (UCVA), contrast sensitivity, intraocular pressure, and assessments of patient satisfaction and quality of life. These will be evaluated using standardized questionnaires such as the VF-14, the PRSIQ spectacle dependency scale, and reading speed tests to quantify changes in vision-related quality of life. Patients will undergo comprehensive ophthalmic examinations preoperatively and at 6 months postoperatively, including slit-lamp anterior segment examination, fundus examination, corneal topography, and intraocular pressure testing. Additionally, questionnaires will be used to assess patients' subjective satisfaction with visual improvement and spectacle needs in daily life. All data will be statistically analyzed to compare the effects of the two types of intraocular lenses. Continuous variables will be analyzed using t-tests or Mann-Whitney U tests, and categorical variables will be analyzed using chi-square tests. The level of statistical significance is set at p<0.05. Through this study, we hope to determine whether the use of EDOF intraocular lenses provides better visual outcomes and quality of life compared to monofocal intraocular lenses in highly myopic patients with cataracts. The results of this study will provide a more scientific basis for the choice of intraocular lenses in clinical practice.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Zhao Yune; Phone Number: 13819707056; Email: zye@mail.eye.ac.cn
• Study Contact Backup: Name: li siyan; Phone Number: 18813185262; Email: syaine@126.com

Study Locations

• China
  • zhejian
    • Hanzhou, zhejian, China, 310000
      • Ophthalmology and Optometry Hos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation"

Description

Inclusion Criteria:

• 1: The patients are between 40 and 70 years old.

  2: Ocular axis > 26mm

  3: Able to understand, cooperate and complete all follow-up.

Exclusion Criteria:

• 1: Moderate and severe dry eye

  2: There is macular degeneration complicated by high myopia.

  3: Combined with other ophthalmic diseases

  4: Previous history of ophthalmic surgery.

  5: There are intraoperative or postoperative complications.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICB00 implantation after cataract surgery.; Undergoing micro-incision cataract surgery with the implantation of an extended depth of focus (EDOF) intraocular lens (ICB).	Other: no intervention; no intervention
ZCB00 implantation after cataract surgery.; Performing micro-incision cataract surgery and implanting a ZCB (presumably an abbreviation specific to a certain type of intraocular lens) intraocular lens	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defocus curve	On the basis of BCDVA, add +2.5~-5.0D spherical lenses (decreasing at intervals of 0.5D) before the patient's operation, record the logMAR vision of the patient at each added spherical lens degree, and draw the average Defocus Curve with the added spherical lens degree as the abscissa and the average vision of each corresponding degree as the ordinate.	Three months after operation
Far, middle and near vision	The naked eye vision was measured at 5m, 70cm and 40cm respectively.	Three months after operation

Collaborators and Investigators

• Sponsor: Wenzhou Medical University
• Investigators: Principal Investigator: Zhao Yune, Ethics Committee of the affiliated Ophthalmology Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: H2025-014-K-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No