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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04006912
Other study ID # xuwen2019-079
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 10, 2019
Est. completion date May 1, 2021

Study information

Verified date December 2020
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Wen Xu, PHD
Phone +86 571 87783897
Email xuwen2003@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To study the Influence of Different Preoperative Decision Schemes on the Visual Quality After Toric Intraocular Lens Implantation


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date May 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 55 Years to 80 Years
Eligibility Inclusion Criteria: 1. Age-related cataract (age 55-80) 2. Corneal astigmatism is greater than 1.0D 3. Patients who are willing to implant Toric IOL Exclusion Criteria: 1. Previous or present eye diseases, such as glaucoma, eye trauma, etc 2. High refractive error 3. Previous eye surgery 4. Irregular astigmatism of the cornea

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
phacoemulsification and Toric intraocular lens implantation
A clear corneal incision is made in a different position

Locations

Country Name City State
China Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Actual residual astigmatism after surgery The actual residual astigmatism value after the operation is measured with the phoropter 1 week postoperation
Primary Actual residual astigmatism after surgery The actual residual astigmatism value after the operation is measured with the phoropter 1 month postoperation
Primary Actual residual astigmatism after surgery The actual residual astigmatism value after the operation is measured with the phoropter 3 month postoperation
Secondary uncorrected distance visual acuity (UDVA) uncorrected distance visual acuity (UDVA) is observed in each group 1 week postoperation
Secondary uncorrected distance visual acuity (UDVA) uncorrected distance visual acuity (UDVA) is observed in each group 1 month postoperation
Secondary uncorrected distance visual acuity (UDVA) uncorrected distance visual acuity (UDVA) is observed in each group 3 month postoperation
Secondary Theoretical residual astigmatism after surgery The theoretical residual astigmatism is obtained by TECNIS Toric online calculator 1 week postoperation
Secondary Theoretical residual astigmatism after surgery The theoretical residual astigmatism is obtained by TECNIS Toric online calculator 1 month postoperation
Secondary Theoretical residual astigmatism after surgery The theoretical residual astigmatism is obtained by TECNIS Toric online calculator 3 month postoperation
Secondary Postoperative Totic intraocular lens rotation angle Postoperative Totic intraocular lens rotation angle is observed in each group 1 week postoperation
Secondary Postoperative Totic intraocular lens rotation angle Postoperative Totic intraocular lens rotation angle is observed in each group 1 month postoperation
Secondary Postoperative Totic intraocular lens rotation angle Postoperative Totic intraocular lens rotation angle is observed in each group 3 month postoperation
Secondary Postoperative astigmatism and astigmatism axial of cornea Postoperative astigmatism and astigmatism axial of cornea are measured with Pentacam 1 week postoperation
Secondary Postoperative astigmatism and astigmatism axial of cornea Postoperative astigmatism and astigmatism axial of cornea are measured with Pentacam 1 month postoperation
Secondary Postoperative astigmatism and astigmatism axial of cornea Postoperative astigmatism and astigmatism axial of cornea are measured with Pentacam 3 month postoperation
Secondary Corneal Aberrations Corneal aberrations are measured with OPD-Scan ? 1 week postoperation
Secondary Corneal Aberrations Corneal aberrations are measured with OPD-Scan ? 1 month postoperation
Secondary Corneal Aberrations Corneal aberrations are measured with OPD-Scan ? 3 month postoperation
See also
  Status Clinical Trial Phase
Recruiting NCT04833491 - Study of the Correlation Between Preoperative Precise Biometrics, Spatial Assessment and Postoperative Visual Quality in Cataract Patients