Clinical trial NCT06905938: Comparing Monofocal IOLs in Highly Myopic Cataract Patients
Official 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.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cataract
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation"

Brief summary: 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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Defocus curve
timeFrame: Three months after operation
measure: Far, middle and near vision
timeFrame: Three months after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: Ophthalmology and Optometry Hos
state: zhejian
Study officials:
affiliation: Ethics Committee of the affiliated Ophthalmology Hospital of Wenzhou Medical University
name: Zhao Yune
role: PRINCIPAL_INVESTIGATOR
References: