Cataract With Pre-existing Regular Corneal AstigmatismNCT07768722
Influence of Implantation Technique on Rotational Stability of a Frosted-Haptic Toric Intraocular Lens: A Prospective Contralateral-Eye Study
A study testing OVD-assisted Implantation and BSS-assisted hydroimplantation in people with Cataract With Pre-existing Regular Corneal Astigmatism, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract With Pre-existing Regular Corneal Astigmatism
- What is being tested?
- OVD-assisted Implantation and BSS-assisted hydroimplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Being tested
- OVD-assisted Implantation, BSS-assisted hydroimplantation
- Keywords
- Cataract surgery, Toric Intraocular Lens, TECNIS Eyhance Toric II, Rotational Stability, Hydroimplantation, Balanced Salt Solution (BSS), Ophthalmic Viscosurgical Device (OVD), Corneal Astigmatism, Refractive Outcomes, Intraocular Lens Implantation
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVD-assisted ImplantationProcedure or surgery
Implantation of the TECNIS Eyhance Toric II intraocular lens using a cohesive ophthalmic viscosurgical device.
BSS-assisted hydroimplantationProcedure or surgery
Implantation of the TECNIS Eyhance Toric II intraocular lens using balanced salt solution instead of an ophthalmic viscosurgical device.
| Study group | Role | What they receive |
|---|---|---|
| OVD-assisted Implantation | Experimental | Implantation of the TECNIS Eyhance Toric II intraocular lens using a cohesive ophthalmic viscosurgical device (ProVisc) during cataract surgery. Receives: Procedure: OVD-assisted Implantation |
| BSS-assisted hydroimplantation | Experimental | Implantation of the TECNIS Eyhance Toric II intraocular lens using balanced salt solution hydroimplantation during cataract surgery. Receives: Procedure: BSS-assisted hydroimplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Postoperative day 1, week 1, and month 1
Secondary outcomes (4)
Residual refractive astigmatism
Postoperative refractive astigmatism measured at the corneal plane by manifest refraction.
Measured: 3 months after surgery
Astigmatic prediction error
Absolute prediction error calculated as the absolute difference between the predicted and postoperative refractive astigmatism.
Measured: 3 months after surgery
Uncorrected Distance Visual Acuity (UDVA)
Monocular uncorrected distance visual acuity measured using a standardized visual acuity chart.
Measured: 3 months after surgery
Corrected Distance Visual Acuity (CDVA)
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start10 Apr 2026
- Primary completion10 Jun 2026
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract With Pre-existing Regular Corneal AstigmatismStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Al Watany Eye Hospital
- Responsible party
- Principal investigator, Menna Kamel, Ain Shams University
- Investigators
- Ahmed Assaf, MD, PhD, Principal investigator, Ainshams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768722
- Sponsor's protocol ID
- 200/2026
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Implantation Technique on Rotational Stability of a Frosted-Haptic Toric Intraocular Lens: A Prospective Contralateral-Eye Study
- ClinicalTrials.gov ID
- NCT07768722
- Acronym / sponsor ID
- 200/2026
- Keywords
- Cataract surgery, Toric Intraocular Lens, TECNIS Eyhance Toric II, Rotational Stability, Hydroimplantation, Balanced Salt Solution (BSS), Ophthalmic Viscosurgical Device (OVD), Corneal Astigmatism
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Al Watany Eye Hospital
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OVD-assisted Implantation | Experimental | Procedure: OVD-assisted ImplantationImplantation of the TECNIS Eyhance Toric II intraocular lens using a cohesive ophthalmic viscosurgical device (ProVisc) during cataract surgery. |
| BSS-assisted hydroimplantation | Experimental | Procedure: BSS-assisted hydroimplantationImplantation of the TECNIS Eyhance Toric II intraocular lens using balanced salt solution hydroimplantation during cataract surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OVD-assisted ImplantationImplantation of the TECNIS Eyhance Toric II intraocular lens using a cohesive ophthalmic viscosurgical device. | Procedure or surgery | OVD-assisted Implantation |
| BSS-assisted hydroimplantationImplantation of the TECNIS Eyhance Toric II intraocular lens using balanced salt solution instead of an ophthalmic viscosurgical device. | Procedure or surgery | BSS-assisted hydroimplantation |
Primary outcome
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
4 secondary outcomes
Residual refractive astigmatism
Time frame: 3 months after surgery
Astigmatic prediction error
Time frame: 3 months after surgery
Uncorrected Distance Visual Acuity (UDVA)
Time frame: 3 months after surgery
Corrected Distance Visual Acuity (CDVA)
Time frame: 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Assaf, MD, PhD principal investigator
Ainshams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OVD-assisted Implantation and BSS-assisted hydroimplantation in people with Cataract With Pre-existing Regular Corneal Astigmatism, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute rotational stability of the TECNIS Eyhance Toric II intraocular lens (time frame: Postoperative day 1, week 1, and month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.