Influence of Implantation Technique on Rotational Stability of a Frosted-Haptic Toric Intraocular Lens: A Prospective Contralateral-Eye Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dr.
-
Cairo, Dr., Egypt, 11765
- AinShams university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: OVD-assisted Implantation
Implantation of the TECNIS Eyhance Toric II intraocular lens using a cohesive ophthalmic viscosurgical device (ProVisc) during cataract surgery.
|
Implantation of the TECNIS Eyhance Toric II intraocular lens using a cohesive ophthalmic viscosurgical device.
|
|
Experimental: BSS-assisted hydroimplantation
Implantation of the TECNIS Eyhance Toric II intraocular lens using balanced salt solution hydroimplantation during cataract surgery.
|
Implantation of the TECNIS Eyhance Toric II intraocular lens using balanced salt solution instead of an ophthalmic viscosurgical device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Absolute rotational stability of the TECNIS Eyhance Toric II intraocular lens
Time Frame: 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
|
Postoperative day 1, week 1, and month 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Residual refractive astigmatism
Time Frame: 3 months after surgery
|
Postoperative refractive astigmatism measured at the corneal plane by manifest refraction.
|
3 months after surgery
|
|
Astigmatic prediction error
Time Frame: 3 months after surgery
|
Absolute prediction error calculated as the absolute difference between the predicted and postoperative refractive astigmatism.
|
3 months after surgery
|
|
Uncorrected Distance Visual Acuity (UDVA)
Time Frame: 3 months after surgery
|
Monocular uncorrected distance visual acuity measured using a standardized visual acuity chart.
|
3 months after surgery
|
|
Corrected Distance Visual Acuity (CDVA)
Time Frame: 3 months after surgery
|
3 months after surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ahmed Assaf, MD, PhD, AinShams university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200/2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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