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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Dr.
-
Cairo, Dr., Egypt, 11765
- AinShams university
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Absolute rotational stability of the TECNIS Eyhance Toric II intraocular lens
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Residual refractive astigmatism
Tidsramme: 3 months after surgery
|
Postoperative refractive astigmatism measured at the corneal plane by manifest refraction.
|
3 months after surgery
|
|
Astigmatic prediction error
Tidsramme: 3 months after surgery
|
Absolute prediction error calculated as the absolute difference between the predicted and postoperative refractive astigmatism.
|
3 months after surgery
|
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Uncorrected Distance Visual Acuity (UDVA)
Tidsramme: 3 months after surgery
|
Monocular uncorrected distance visual acuity measured using a standardized visual acuity chart.
|
3 months after surgery
|
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Corrected Distance Visual Acuity (CDVA)
Tidsramme: 3 months after surgery
|
3 months after surgery
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ahmed Assaf, MD, PhD, AinShams university
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 200/2026
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