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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04006912

Collaborator

(none)

Enrollment

Location

Arms

24.7

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Recruitment of Participants	Procedure: phacoemulsification and Toric intraocular lens implantation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 10, 2019

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

May 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Actual residual astigmatism after surgery [1 week postoperation]
The actual residual astigmatism value after the operation is measured with the phoropter
Actual residual astigmatism after surgery [1 month postoperation]
The actual residual astigmatism value after the operation is measured with the phoropter
Actual residual astigmatism after surgery [3 month postoperation]
The actual residual astigmatism value after the operation is measured with the phoropter

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age-related cataract (age 55-80)
Corneal astigmatism is greater than 1.0D
Patients who are willing to implant Toric IOL

Exclusion Criteria:

Previous or present eye diseases, such as glaucoma, eye trauma, etc
High refractive error
Previous eye surgery
Irregular astigmatism of the cornea

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04006912

Other Study ID Numbers:

xuwen2019-079

First Posted:

Jul 5, 2019

Last Update Posted:

Apr 5, 2021

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 5, 2021