Cataract, High Myopia
Conditions
Keywords
high myopia, cataract, impaired visual acuity
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 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.
Interventions
PROCEDUREEnhanced monofocal intraocular lens implantation (monovision strategy)
Participants 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 \[Emmetropia Verifying Optical (EVO) version 2.0, Kane, LISA\].
PROCEDUREEnhanced monofocal intraocular lens implantation (bilateral myopia strategy)
Participants 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 \[Emmetropia Verifying Optical (EVO) version 2.0, Kane, LISA\].
Sponsors
Shenzhen Eye Hospital
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 85 years (inclusive), no gender restrictions; 2. Scheduled to undergo bilateral phacoemulsification with intraocular lens implantation; 3. Axial length ≥ 26.0 mm in both eyes; 4. Desire for postoperative spectacle independence; 5. Able to understand and cooperate with the trial procedures, voluntarily participate in this clinical trial, and sign an informed consent form.
Exclusion criteria
1. Poor-quality preoperative ocular biometry (Axial length, keratometry, anterior chamber depth); 2. Preoperative corneal astigmatism ≥ 1.5 diopters (D); 3. Patients with intraoperative or postoperative complications (ie, intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, etc.); 4. The presence of other ocular diseases (ie, strabismus, severe retinal pathology, uveitis, other relevant ophthalmic diseases that might affect outcomes or trauma, etc.); 5. A history of intraocular surgery; 6. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular uncorrected distance visual acuity at 4 m | 3 months (±2 weeks) following the second eye surgery | measured by the ETDRS chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monocular and binocular uncorrected near visual acuity at 40cm | 1, 3, 6, 12 months following the second eye surgery | measured by the EDTRS chart |
| Stereoscopic vision | 3, 6, 12 months following the second eye surgery | — |
| Patient-reported outcome measures (PROMs): Vision-specific quality of life | 3, 6, 12 months following the second eye surgery | Vision-specific quality of life is measured by the Chinese version of the 9-item short-form of the Catquest questionnaire (Catquest-9SF). There are five text response options for the answers, scaled from Yes, very great difficulties to No, no difficulties, including the answer Cannot decide. The minimum score is 9, and the maximum score is 36. |
| Patient-reported outcome measures (PROMs): Photic phenomena | 3, 6, 12 months following the second eye surgery | Pictures from the Quality of Vision (QoV) questionnaire were shown to patients, who were then asked to rate the frequency (never, occasionally, quite often, very often), severity (none, mild, moderate, severe) of photic phenomena and the extent to which these phenomena interfered with daily life (not at all, a little, quite, very). |
| Patient-reported outcome measures (PROMs): Spectacle independence | 3, 6, 12 months following the second eye surgery | Spectacle independence is measured by a self-made spectacle independence questionnaire. Patients will be asked about the frequency of spectacle independence at the distance, intermediate, and near distances. There are three text response options for the answers, including Always, Seldom, and Never. |
| Monocular and binocular uncorrected intermediate visual acuity at 80cm and 60cm | 1, 3, 6, 12 months following the second eye surgery | measured by the EDTRS chart |
| Monocular and binocular uncorrected distance visual acuity at 4 m | 1, 6, 12 months following the second eye surgery | measured by the ETDRS chart |
| Monocular and binocular defocus curves | 3, 6, 12 months following the second eye surgery | measured by the binoptometer 4P |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative or postoperative complications | 1, 3, 6, 12 months following the second eye surgery | Clinical manifestations are assessed and recorded by the ophthalmologist. |
| Self-reported incidence and severity of ocular discomfort | 1, 3, 6, 12 months following the second eye surgery | collected by self-reported outcomes and past medical records (if any) of participants |
| Binocular contrast sensitivity | 3, 6, 12 months following the second eye surgery | — |
| Reading ability | 3, 6, 12 months following the second eye surgery | measured by the International Reading Speed Texts (IResT) |
Contacts
Primary ContactLixia Luo
Backup ContactDanyue Chen
Outcome results
None listed