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NCT Number: NCT06905938

Comparing Monofocal IOLs in Highly Myopic Cataract Patients

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)

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Ophthalmology and Optometry Hos

Hanzhou, Zhejian, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. Defocus curve

    Time frame: Three months after operation

    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.

  2. Far, middle and near vision

    Time frame: Three months after operation

    The naked eye vision was measured at 5m, 70cm and 40cm respectively.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhao Yune

CONTACT

[email protected]

13819707056

li siyan

CONTACT

[email protected]

18813185262

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

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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