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 length ≥ 26 mm).
The main questions it aims to answer are:
For people with cataract and high myopia, does an enhanced monofocal intraocular lens targeted for monovision provide greater binocular uncorrected distance visual acuity compared with targeting myopia in both eyes? Does an enhanced monofocal intraocular lens targeted for monovision provide comparable binocular uncorrected intermediate and near visual acuity, contrast sensitivity, reading ability, spectacle independence, stereopsis, and photic phenomena compared with targeting myopia in both eyes?
Researchers will compare an enhanced monofocal intraocular lens targeted for monovision with one targeted for myopia in both eyes to determine whether the monovision strategy is more effective.
Participants will:
Undergo phacoemulsification with enhanced monofocal intraocular lens implantation. Attend follow-up visits at 1, 3, 6, and 12 months after cataract surgery.
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;
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.);
Parallel
Enhanced monofocal intraocular lens implantation (monovision strategy)
Procedure/SurgeryParticipants will undergo phacoemulsification with the implantation of an enhanced monofocal intraocular lens, targeting -0.5 D in the dominant eye and -2.0 D in the non-dominant eye. The first operated eye will be selected based on the worse corrected distance visual acuity; if both eyes are similar, the eye subjectively perceived by the patient as having worse vision will be chosen. The second eye surgery will be performed within 2 weeks after the first eye surgery. Ocular dominance will be determined preoperatively using the "finger method" . Intraocular lens power will be calculated using multiple formulas \[Emmetropia Verifying Optical (EVO) version 2.0, Kane, LISA\].
Enhanced monofocal intraocular lens implantation (bilateral myopia strategy)
Procedure/SurgeryParticipants will undergo phacoemulsification with the implantation of an enhanced monofocal intraocular lens, targeting -2.0 D in both eyes. The first operated eye will be selected based on the worse corrected distance visual acuity; if both eyes are similar, the eye subjectively perceived by the patient as having worse vision will be chosen. The second eye surgery will be performed within 2 weeks after the first eye surgery. Ocular dominance will be determined preoperatively using the "finger method". Intraocular lens power will be calculated using multiple formulas \[Emmetropia Verifying Optical (EVO) version 2.0, Kane, LISA\].
Binocular uncorrected distance visual acuity at 4 m
measured by the ETDRS chart
Monocular and binocular uncorrected distance visual acuity at 4 m
measured by the ETDRS chart
Monocular and binocular uncorrected intermediate visual acuity at 80cm and 60cm
measured by the EDTRS chart
Monocular and binocular uncorrected near visual acuity at 40cm
measured by the EDTRS chart
Monocular and binocular defocus curves
measured by the binoptometer 4P
Binocular contrast sensitivity
Reading ability
measured by the International Reading Speed Texts (IResT)
Intraoperative or postoperative complications
Clinical manifestations are assessed and recorded by the ophthalmologist.
Self-reported incidence and severity of ocular discomfort
collected by self-reported outcomes and past medical records (if any) of participants
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Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead sponsor
Shenzhen Eye Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
