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| Name | Class |
|---|---|
| Shenzhen Eye Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monovision group | Experimental | Both eyes will be implanted with enhanced monofocal intraocular lenses, with the dominant eye targeted for -0.5 diopters (D) and the nondominant eye for -2.0 D. |
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| Bilateral myopia group | Active Comparator | Both eyes will be implanted with enhanced monofocal intraocular lenses, with each eye targeted for -2.0 D. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced monofocal intraocular lens implantation (monovision strategy) | Procedure | 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]. |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular uncorrected distance visual acuity at 4 m | measured by the ETDRS chart | 3 months (±2 weeks) following the second eye surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular and binocular uncorrected distance visual acuity at 4 m | measured by the ETDRS chart | 1, 6, 12 months following the second eye surgery |
| Monocular and binocular uncorrected intermediate visual acuity at 80cm and 60cm |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular contrast sensitivity | 3, 6, 12 months following the second eye surgery | |
| Reading ability | measured by the International Reading Speed Texts (IResT) | 3, 6, 12 months following the second eye surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lixia Luo | Contact | +8618665666679 | luolixia@mail.sysu.edu.cn | |
| Danyue Chen | Contact | +8615989073809 | chendy68@mail2.sysu.edu.cn |
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| Enhanced monofocal intraocular lens implantation (bilateral myopia strategy) | Procedure | 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]. |
|
measured by the EDTRS chart
| 1, 3, 6, 12 months following the second eye surgery |
| Monocular and binocular uncorrected near visual acuity at 40cm | measured by the EDTRS chart | 1, 3, 6, 12 months following the second eye surgery |
| Monocular and binocular defocus curves | measured by the binoptometer 4P | 3, 6, 12 months following the second eye surgery |
| Stereoscopic vision | 3, 6, 12 months following the second eye surgery |
| Patient-reported outcome measures (PROMs): Vision-specific quality of life | 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. | 3, 6, 12 months following the second eye surgery |
| Patient-reported outcome measures (PROMs): Photic phenomena | 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). | 3, 6, 12 months following the second eye surgery |
| Patient-reported outcome measures (PROMs): Spectacle independence | 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". | 3, 6, 12 months following the second eye surgery |
| Intraoperative or postoperative complications | Clinical manifestations are assessed and recorded by the ophthalmologist. | 1, 3, 6, 12 months following the second eye surgery |
| Self-reported incidence and severity of ocular discomfort | collected by self-reported outcomes and past medical records (if any) of participants | 1, 3, 6, 12 months following the second eye surgery |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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