Cataract
Conditions
Keywords
toric intraocular lens, rotational stability, cataract, astigmatism
Brief summary
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.
Interventions
DEVICETECNIS Toric II (ZCU)
Using TECNIS Toric II (ZCU) intraocular lens during standard phacoemulsification cataract surgery.
DEVICEAcrySof IQ Toric
Using AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery.
DEVICEAT TORBI 709M
Using the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery.
Sponsors
Jin Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Outcome assessors were masked to IOL type.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older with age-related cataract scheduled for phacoemulsification cataract surgery. * Presence of regular corneal astigmatism requiring toric intraocular lens implantation. * Eligible for implantation of one of the three study toric intraocular lenses based on preoperative evaluation. * Ability to understand the study procedures and provide written informed consent.
Exclusion criteria
* History of prior ocular surgery in the study eye. * History of ocular trauma in the study eye. * Irregular corneal astigmatism or corneal pathology affecting reliable biometric measurement. * Intraoperative complications, including anterior capsular tear or posterior capsular rupture. * Inadequate pupillary dilation during surgery or postoperative examinations. * Evidence of zonular weakness, zonular dialysis, or lens subluxation. * Active ocular infection or inflammation. * Any other ocular or systemic condition judged by the investigator to potentially affect intraocular lens stability or study outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute rotational misalignment of toric intraocular lens (IOL) measured in degrees | Postoperative day 1, day 3, week 1, week 2, month 1, and month 3. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected and corrected distance visual acuity (UDVA and CDVA) | postoperatively on 1 day, 3 days, 1 week, 2 weeks, 1 month and 3 months | 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. |
| Postoperative residual refractive astigmatism measured in diopters | Postoperative day 1, day 3, week 1, week 2, month 1, and month 3. | Residual refractive astigmatism measured by manifest refraction during follow-up visits and reported in diopters (D). |
Countries
China
Contacts
CONTACTXuanqiao Lin
PRINCIPAL_INVESTIGATORJin Yang
Fudan University
Outcome results
None listed