An observational study in Cataract, sponsored by Wenzhou Medical University. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Wenzhou Medical University · Observational
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)
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 60 is below the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →Wenzhou Medical University is the lead sponsor of 94 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation"
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Undergoing micro-incision cataract surgery with the implantation of an extended depth of focus (EDOF) intraocular lens (ICB).
Other: no intervention
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
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.
Time frame: Three months after operation
Far, middle and near vision
The naked eye vision was measured at 5m, 70cm and 40cm respectively.
Time frame: Three months after operation
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2025; primary completion for May 2026, 13 months later.
Of 167 non-industry observational studies under Cataract, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's planned 13 months is below that.
Counting every sponsor, half of 234 studies reached it within 16 months; a quarter within 9 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Wenzhou Medical University