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Clinical Trials in Egypt / NCT07768722
Active, not recruiting Not applicable

Influence of Implantation Technique on Rotational Stability of a Frosted-Haptic Toric Intraocular Lens: A Prospective Contralateral-Eye Study

NCT07768722 · tracked via the Priya Life Science Egypt tracker
Sponsor
Ain Shams University
Phase
Not applicable
Started
2026-04-10
Last updated
2026-08-17

Condition(s) studied

Cataract With Pre-existing Regular Corneal Astigmatism

Investigational drug(s) / intervention(s)

OVD-assisted ImplantationBSS-assisted hydroimplantation

OVD-assisted Implantation: Implantation of the TECNIS Eyhance Toric II intraocular lens using a cohesive ophthalmic viscosurgical device.

BSS-assisted hydroimplantation: Implantation of the TECNIS Eyhance Toric II intraocular lens using balanced salt solution instead of an ophthalmic viscosurgical device.

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Ainshams University Cairo Dr.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07768722 on ClinicalTrials.gov ↗ ← All trials in Egypt