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NCT Number: NCT07768722

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cataract With Pre-existing Regular Corneal Astigmatism Astigmatism Eye Diseases Refractive Errors

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ainshams University

Cairo, Dr., 11765, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OVD-assisted Implantation

Procedure

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

BSS-assisted hydroimplantation

Procedure

Implantation of the TECNIS Eyhance Toric II intraocular lens using balanced salt solution instead of an ophthalmic viscosurgical device.

Primary outcomes

  1. 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

Secondary outcomes

  1. Residual refractive astigmatism

    Time frame: 3 months after surgery

    Postoperative refractive astigmatism measured at the corneal plane by manifest refraction.

  2. 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. Uncorrected Distance Visual Acuity (UDVA)

    Time frame: 3 months after surgery

    Monocular uncorrected distance visual acuity measured using a standardized visual acuity chart.

  4. Corrected Distance Visual Acuity (CDVA)

    Time frame: 3 months after surgery

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Al Watany Eye Hospital

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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