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| ID | Type | Description | Link |
|---|---|---|---|
| 82171039 | Other Grant/Funding Number | National Natural Science Foundation of China |
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This prospective comparative cohort study evaluates and compares postoperative rotational stability and time-course dynamics of three commercially available toric intraocular lenses (TECNIS Toric II [ZCU], AcrySof IQ Toric, and AT TORBI 709M) after phacoemulsification cataract surgery. Rotation is quantified by registering postoperative retroillumination photographs to the end-of-surgery baseline using iris/scleral landmarks, with follow-up at postoperative day 1, day 3, week 1, week 2, month 1, and month 3. Associations between rotational outcomes and ocular biometric parameters are analyzed using linear mixed-effects models to inform individualized IOL selection and perioperative management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TECNIS Toric II (ZCU) | Active Comparator | Participants randomized to this arm receive implantation of the TECNIS Toric II (ZCU) intraocular lens during standard phacoemulsification cataract surgery. |
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| AcrySof IQ Toric | Active Comparator | Participants randomized to this arm receive implantation of the AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery. |
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| AT TORBI 709M | Active Comparator | Participants randomized to this arm receive implantation of the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TECNIS Toric II (ZCU) | Device | Using TECNIS Toric II (ZCU) intraocular lens during standard phacoemulsification cataract surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute rotational misalignment of toric intraocular lens (IOL) measured in degrees | Absolute rotation of the implanted toric intraocular lens (IOL) relative to the intended axis, measured in degrees. Rotation will be quantified by registering postoperative retroillumination images to the end-of-surgery baseline frame using iris or scleral landmarks. The absolute rotation angle will be calculated for each follow-up visit. | Postoperative day 1, day 3, week 1, week 2, month 1, and month 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected and corrected distance visual acuity (UDVA and CDVA) | Uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) measured using a standardized logarithm of the minimum angle of resolution (logMAR) visual acuity chart during follow-up. | postoperatively on 1 day, 3 days, 1 week, 2 weeks, 1 month and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuanqiao Lin | Contact | +8615088920668 | 1532483480@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin Yang | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye and ENT hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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Outcome assessors were masked to IOL type.
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| AcrySof IQ Toric | Device | Using AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery. |
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| AT TORBI 709M | Device | Using the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery. |
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| Postoperative residual refractive astigmatism measured in diopters | Residual refractive astigmatism measured by manifest refraction during follow-up visits and reported in diopters (D). | Postoperative day 1, day 3, week 1, week 2, month 1, and month 3. |