Status:
NOT_YET_RECRUITING
Visual Outcomes of an Enhanced Monofocal Intraocular Lens Targeted for Monovision in Highly Myopic Eyes: a Randomized Controlled Trial
Lead Sponsor:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Collaborating Sponsors:
Shenzhen Eye Hospital
Conditions:
Cataract
High Myopia
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate whether an enhanced monofocal intraocular lens targeted for monovision can improve visual outcomes in patients with cataract and high myopia (axial lengt...
Eligibility Criteria
Inclusion
- Age between 18 and 85 years (inclusive), no gender restrictions;
- Scheduled to undergo bilateral phacoemulsification with intraocular lens implantation;
- Axial length ≥ 26.0 mm in both eyes;
- Desire for postoperative spectacle independence;
- Able to understand and cooperate with the trial procedures, voluntarily participate in this clinical trial, and sign an informed consent form.
Exclusion
- Poor-quality preoperative ocular biometry (Axial length, keratometry, anterior chamber depth);
- Preoperative corneal astigmatism ≥ 1.5 diopters (D);
- Patients with intraoperative or postoperative complications (ie, intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, etc.);
- The presence of other ocular diseases (ie, strabismus, severe retinal pathology, uveitis, other relevant ophthalmic diseases that might affect outcomes or trauma, etc.);
- A history of intraocular surgery;
- Severe chronic systemic diseases, psychiatric disorders, dementia, hearing impairments, or mobility limitations that would interfere with understanding of the monovision design, attendance at follow-up visits, or completion of questionnaires.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT07168109
Start Date
October 1 2025
End Date
July 1 2027
Last Update
September 18 2025
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