An interventional study of OVD-assisted Implantation and BSS-assisted hydroimplantation in Cataract With Pre-existing Regular Corneal Astigmatism, sponsored by Ain Shams University. Active, not recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Irregular corneal astigmatism or corneal opacity.
Implantation of the TECNIS Eyhance Toric II intraocular lens using a cohesive ophthalmic viscosurgical device (ProVisc) during cataract surgery.
Procedure: OVD-assisted Implantation
Implantation of the TECNIS Eyhance Toric II intraocular lens using balanced salt solution hydroimplantation during cataract surgery.
Procedure: BSS-assisted hydroimplantation
Implantation of the TECNIS Eyhance Toric II intraocular lens using a cohesive ophthalmic viscosurgical device.
Implantation of the TECNIS Eyhance Toric II intraocular lens using balanced salt solution instead of an ophthalmic viscosurgical device.
Absolute rotational stability of the TECNIS Eyhance Toric II intraocular lens
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
Time frame: Postoperative day 1, week 1, and month 1
Residual refractive astigmatism
Postoperative refractive astigmatism measured at the corneal plane by manifest refraction.
Time frame: 3 months after surgery
Astigmatic prediction error
Absolute prediction error calculated as the absolute difference between the predicted and postoperative refractive astigmatism.
Time frame: 3 months after surgery
Uncorrected Distance Visual Acuity (UDVA)
Monocular uncorrected distance visual acuity measured using a standardized visual acuity chart.
Time frame: 3 months after surgery
Corrected Distance Visual Acuity (CDVA)
Time frame: 3 months after surgery
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Ain Shams University