Cataract With Pre-existing Regular Corneal Astigmatism
Conditions
Keywords
Cataract surgery, Toric Intraocular Lens, TECNIS Eyhance Toric II, Rotational Stability, Hydroimplantation, Balanced Salt Solution (BSS), Ophthalmic Viscosurgical Device (OVD), Corneal Astigmatism, Refractive Outcomes, Intraocular Lens Implantation
Brief summary
This prospective, randomized contralateral-eye study evaluates whether the implantation technique influences the rotational stability and refractive outcomes of the TECNIS Eyhance™ Toric II intraocular lens (IOL) during cataract surgery. Although balanced salt solution (BSS) hydroimplantation has been proposed to reduce postoperative IOL rotation by eliminating retained ophthalmic viscosurgical device (OVD), the effect of implantation technique on the rotational stability of modern frosted-haptic toric IOLs remains uncertain. Patients undergoing bilateral cataract surgery with regular corneal astigmatism receive TECNIS Eyhance™ Toric II IOLs in both eyes. One eye is randomized to OVD-assisted implantation and the fellow eye to BSS-assisted hydroimplantation. The primary outcome is postoperative rotational stability assessed using OPD-Scan III at postoperative day 1, week 1, and month 1. Secondary outcomes include postoperative refractive astigmatism, astigmatic prediction error, and visual acuity. The study aims to determine whether implantation technique influences postoperative rotational stability or refractive performance when using a contemporary frosted-haptic toric IOL.
Interventions
PROCEDUREOVD-assisted Implantation
Implantation of the TECNIS Eyhance Toric II intraocular lens using a cohesive ophthalmic viscosurgical device.
PROCEDUREBSS-assisted hydroimplantation
Implantation of the TECNIS Eyhance Toric II intraocular lens using balanced salt solution instead of an ophthalmic viscosurgical device.
Sponsors
Ain Shams University
Al Watany Eye Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Adults with senile cataract requiring bilateral cataract surgery. * Regular corneal astigmatism of ≥1.00 diopter. * Axial length between 22.0 mm and 25.0 mm. * Eligible for implantation with the TECNIS Eyhance™ Toric II intraocular lens. * Able and willing to provide written informed consent.
Exclusion criteria
* Inconsistent corneal astigmatism measurements (difference \>0.20 D in magnitude or \>5° in axis among the four diagnostic devices). * Visually significant dry eye disease with positive corneal fluorescein staining. Irregular corneal astigmatism or corneal opacity. * Ocular comorbidities that could affect toric IOL stability or visual outcomes (e.g., pseudoexfoliation syndrome, advanced glaucoma, or macular pathology). * Intraoperative complications or generalized zonular weakness requiring implantation of a capsular tension ring. * Significant postoperative day 1 corneal edema precluding reliable rotational measurements. * Inability to comply with the follow-up schedule.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute rotational stability of the TECNIS Eyhance Toric II intraocular lens | Postoperative day 1, week 1, and month 1 | Absolute intraocular lens rotation (degrees) measured relative to the final intraoperative implantation axis using the OPD-Scan III. Rotation was calculated as the absolute angular difference between the intraoperative reference axis and the postoperative axis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual refractive astigmatism | 3 months after surgery | Postoperative refractive astigmatism measured at the corneal plane by manifest refraction. |
| Astigmatic prediction error | 3 months after surgery | Absolute prediction error calculated as the absolute difference between the predicted and postoperative refractive astigmatism. |
| Uncorrected Distance Visual Acuity (UDVA) | 3 months after surgery | Monocular uncorrected distance visual acuity measured using a standardized visual acuity chart. |
| Corrected Distance Visual Acuity (CDVA) | 3 months after surgery | — |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORAhmed Assaf, MD, PhD
Ainshams University
Outcome results
None listed