Recruitment of ParticipantsNCT04006912
The Influence of Different Preoperative Decision Schemes on the Visual Quality After Toric Intraocular Lens Implantation
A study testing phacoemulsification and Toric intraocular lens implantation in people with Recruitment of Participants, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To study the Influence of Different Preoperative Decision Schemes on the Visual Quality After Toric Intraocular Lens Implantation Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Recruitment of Participants
- What is being tested?
- phacoemulsification and Toric intraocular lens implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2019to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age-related cataract (age 55-80)
- Corneal astigmatism is greater than 1.0D
- Patients who are willing to implant Toric IOL
Who cannot join
- Previous or present eye diseases, such as glaucoma, eye trauma, etc
- High refractive error
- Previous eye surgery
- Irregular astigmatism of the cornea
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
wen Xu, PHD, +86 571 87783897, xuwen2003@zju.edu.cn
About this study
To study the Influence of Different Preoperative Decision Schemes on the Visual Quality After Toric Intraocular Lens Implantation
- Conditions
- Recruitment of Participants
- Being tested
- phacoemulsification and Toric intraocular lens implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsification and Toric intraocular lens implantationProcedure or surgery
A clear corneal incision is made in a different position
| Study group | Role | What they receive |
|---|---|---|
| Minimal residual theoretical astigmatism group | Experimental | Not described Receives: Procedure: phacoemulsification and Toric intraocular lens implantation |
| Steep meridian incision design group | Active comparator | Not described Receives: Procedure: phacoemulsification and Toric intraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actual residual astigmatism after surgery
The actual residual astigmatism value after the operation is measured with the phoropter
Measured: 1 week postoperation
Actual residual astigmatism after surgery
The actual residual astigmatism value after the operation is measured with the phoropter
Measured: 1 month postoperation
Actual residual astigmatism after surgery
The actual residual astigmatism value after the operation is measured with the phoropter
Measured: 3 month postoperation
Secondary outcomes (15)
uncorrected distance visual acuity (UDVA)
uncorrected distance visual acuity (UDVA) is observed in each group
Measured: 1 week postoperation
uncorrected distance visual acuity (UDVA)
uncorrected distance visual acuity (UDVA) is observed in each group
Measured: 1 month postoperation
uncorrected distance visual acuity (UDVA)
uncorrected distance visual acuity (UDVA) is observed in each group
Measured: 3 month postoperation
Theoretical residual astigmatism after surgery
The theoretical residual astigmatism is obtained by TECNIS Toric online calculator
Measured: 1 week postoperation
Theoretical residual astigmatism after surgery
The theoretical residual astigmatism is obtained by TECNIS Toric online calculator
Measured: 1 month postoperation
Theoretical residual astigmatism after surgery
The theoretical residual astigmatism is obtained by TECNIS Toric online calculator
Measured: 3 month postoperation
Postoperative Totic intraocular lens rotation angle
Postoperative Totic intraocular lens rotation angle is observed in each group
Measured: 1 week postoperation
Postoperative Totic intraocular lens rotation angle
Postoperative Totic intraocular lens rotation angle is observed in each group
Measured: 1 month postoperation
Postoperative Totic intraocular lens rotation angle
Postoperative Totic intraocular lens rotation angle is observed in each group
Measured: 3 month postoperation
Postoperative astigmatism and astigmatism axial of cornea
Postoperative astigmatism and astigmatism axial of cornea are measured with Pentacam
Measured: 1 week postoperation
Postoperative astigmatism and astigmatism axial of cornea
Postoperative astigmatism and astigmatism axial of cornea are measured with Pentacam
Measured: 1 month postoperation
Postoperative astigmatism and astigmatism axial of cornea
Postoperative astigmatism and astigmatism axial of cornea are measured with Pentacam
Measured: 3 month postoperation
Corneal Aberrations
Corneal aberrations are measured with OPD-Scan Ⅲ
Measured: 1 week postoperation
Corneal Aberrations
Corneal aberrations are measured with OPD-Scan Ⅲ
Measured: 1 month postoperation
Corneal Aberrations
Corneal aberrations are measured with OPD-Scan Ⅲ
Measured: 3 month postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start10 Apr 2019
- Primary completion1 Apr 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recruitment of ParticipantsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006912
- Sponsor's protocol ID
- xuwen2019-079
- Status last verified
- Dec 2020
- First submitted
- 25 Jun 2019
- Last updated
- 5 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu X, Wang J, Lin X, Xu D, Ni S, Sheng S, Xu W. Effect of two different preoperative calculation schemes on visual outcomes of patients after toric intraocular lens implantation. Int Ophthalmol. 2023 Feb;43(2):491-501. doi: 10.1007/s10792-022-02447-7. Epub 2022 Aug 6.
PubMed 35932419
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Different Preoperative Decision Schemes on the Visual Quality After Toric Intraocular Lens Implantation
- ClinicalTrials.gov ID
- NCT04006912
- Acronym / sponsor ID
- xuwen2019-079
- Conditions
- Recruitment of Participants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 5 Jul 2019 (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.
To study the Influence of Different Preoperative Decision Schemes on the Visual Quality After Toric Intraocular Lens Implantation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal residual theoretical astigmatism group | Experimental | Procedure: phacoemulsification and Toric intraocular lens implantation |
| Steep meridian incision design group | Active comparator | Procedure: phacoemulsification and Toric intraocular lens implantation |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age-related cataract (age 55-80)
- Corneal astigmatism is greater than 1.0D
- Patients who are willing to implant Toric IOL
Key exclusion criteria (4 listed)
- Previous or present eye diseases, such as glaucoma, eye trauma, etc
- High refractive error
- Previous eye surgery
- Irregular astigmatism of the cornea
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 |
|---|---|---|
| phacoemulsification and Toric intraocular lens implantationA clear corneal incision is made in a different position | Procedure or surgery | Minimal residual theoretical astigmatism group, Steep meridian incision design group |
Primary outcome
Actual residual astigmatism after surgery
Time frame: 1 week postoperation
The actual residual astigmatism value after the operation is measured with the phoropter
Actual residual astigmatism after surgery
Time frame: 1 month postoperation
The actual residual astigmatism value after the operation is measured with the phoropter
Actual residual astigmatism after surgery
Time frame: 3 month postoperation
The actual residual astigmatism value after the operation is measured with the phoropter
15 secondary outcomes
uncorrected distance visual acuity (UDVA)
Time frame: 1 week postoperation
uncorrected distance visual acuity (UDVA)
Time frame: 1 month postoperation
uncorrected distance visual acuity (UDVA)
Time frame: 3 month postoperation
Theoretical residual astigmatism after surgery
Time frame: 1 week postoperation
Theoretical residual astigmatism after surgery
Time frame: 1 month postoperation
Theoretical residual astigmatism after surgery
Time frame: 3 month postoperation
Postoperative Totic intraocular lens rotation angle
Time frame: 1 week postoperation
Postoperative Totic intraocular lens rotation angle
Time frame: 1 month postoperation
Postoperative Totic intraocular lens rotation angle
Time frame: 3 month postoperation
Postoperative astigmatism and astigmatism axial of cornea
Time frame: 1 week postoperation
Postoperative astigmatism and astigmatism axial of cornea
Time frame: 1 month postoperation
Postoperative astigmatism and astigmatism axial of cornea
Time frame: 3 month postoperation
Corneal Aberrations
Time frame: 1 week postoperation
Corneal Aberrations
Time frame: 1 month postoperation
Corneal Aberrations
Time frame: 3 month postoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Derived from this study: PubMed 35932419Yu X, Wang J, Lin X, Xu D, Ni S, Sheng S, Xu W. Effect of two different preoperative calculation schemes on visual outcomes of patients after toric intraocular lens implantation. Int Ophthalmol. 2023 Feb;43(2):491-501. doi: 10.1007/s10792-022-02447-7. Epub 2022 Aug 6.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phacoemulsification and Toric intraocular lens implantation in people with Recruitment of Participants, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Apr 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen Xu, PHD (+86 571 87783897, xuwen2003@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actual residual astigmatism after surgery (time frame: 1 week postoperation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04006912, which also lists 1 linked publication.
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 5 Apr 2021.