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

April 2, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
To study the Influence of Different Preoperative Decision Schemes on the Visual Quality After Toric Intraocular Lens Implantation

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Second Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Minimal residual theoretical astigmatism group
Procedure: phacoemulsification and Toric intraocular lens implantation
A clear corneal incision is made in a different position
Active Comparator: Steep meridian incision design group
Procedure: phacoemulsification and Toric intraocular lens implantation
A clear corneal incision is made in a different position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Actual residual astigmatism after surgery
Time Frame: 1 week postoperation
The actual residual astigmatism value after the operation is measured with the phoropter
1 week postoperation
Actual residual astigmatism after surgery
Time Frame: 1 month postoperation
The actual residual astigmatism value after the operation is measured with the phoropter
1 month postoperation
Actual residual astigmatism after surgery
Time Frame: 3 month postoperation
The actual residual astigmatism value after the operation is measured with the phoropter
3 month postoperation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
uncorrected distance visual acuity (UDVA)
Time Frame: 1 week postoperation
uncorrected distance visual acuity (UDVA) is observed in each group
1 week postoperation
uncorrected distance visual acuity (UDVA)
Time Frame: 1 month postoperation
uncorrected distance visual acuity (UDVA) is observed in each group
1 month postoperation
uncorrected distance visual acuity (UDVA)
Time Frame: 3 month postoperation
uncorrected distance visual acuity (UDVA) is observed in each group
3 month postoperation
Theoretical residual astigmatism after surgery
Time Frame: 1 week postoperation
The theoretical residual astigmatism is obtained by TECNIS Toric online calculator
1 week postoperation
Theoretical residual astigmatism after surgery
Time Frame: 1 month postoperation
The theoretical residual astigmatism is obtained by TECNIS Toric online calculator
1 month postoperation
Theoretical residual astigmatism after surgery
Time Frame: 3 month postoperation
The theoretical residual astigmatism is obtained by TECNIS Toric online calculator
3 month postoperation
Postoperative Totic intraocular lens rotation angle
Time Frame: 1 week postoperation
Postoperative Totic intraocular lens rotation angle is observed in each group
1 week postoperation
Postoperative Totic intraocular lens rotation angle
Time Frame: 1 month postoperation
Postoperative Totic intraocular lens rotation angle is observed in each group
1 month postoperation
Postoperative Totic intraocular lens rotation angle
Time Frame: 3 month postoperation
Postoperative Totic intraocular lens rotation angle is observed in each group
3 month postoperation
Postoperative astigmatism and astigmatism axial of cornea
Time Frame: 1 week postoperation
Postoperative astigmatism and astigmatism axial of cornea are measured with Pentacam
1 week postoperation
Postoperative astigmatism and astigmatism axial of cornea
Time Frame: 1 month postoperation
Postoperative astigmatism and astigmatism axial of cornea are measured with Pentacam
1 month postoperation
Postoperative astigmatism and astigmatism axial of cornea
Time Frame: 3 month postoperation
Postoperative astigmatism and astigmatism axial of cornea are measured with Pentacam
3 month postoperation
Corneal Aberrations
Time Frame: 1 week postoperation
Corneal aberrations are measured with OPD-Scan Ⅲ
1 week postoperation
Corneal Aberrations
Time Frame: 1 month postoperation
Corneal aberrations are measured with OPD-Scan Ⅲ
1 month postoperation
Corneal Aberrations
Time Frame: 3 month postoperation
Corneal aberrations are measured with OPD-Scan Ⅲ
3 month postoperation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2019

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

April 5, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • xuwen2019-079

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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