NCT04006912

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

April 5, 2021

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

June 25, 2019

Last Update Submit

April 2, 2021

Conditions

Recruitment of Participants

Outcome Measures

Primary Outcomes (3)

  • Actual residual astigmatism after surgery

    The actual residual astigmatism value after the operation is measured with the phoropter

    1 week postoperation

  • Actual residual astigmatism after surgery

    The actual residual astigmatism value after the operation is measured with the phoropter

    1 month postoperation

  • Actual residual astigmatism after surgery

    The actual residual astigmatism value after the operation is measured with the phoropter

    3 month postoperation

Secondary Outcomes (15)

  • uncorrected distance visual acuity (UDVA)

    1 week postoperation

  • uncorrected distance visual acuity (UDVA)

    1 month postoperation

  • uncorrected distance visual acuity (UDVA)

    3 month postoperation

  • Theoretical residual astigmatism after surgery

    1 week postoperation

  • Theoretical residual astigmatism after surgery

    1 month postoperation

  • +10 more secondary outcomes

Study Arms (2)

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

Interventions

phacoemulsification and Toric intraocular lens implantationPROCEDURE

A clear corneal incision is made in a different position

Minimal residual theoretical astigmatism groupSteep meridian incision design group

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35932419DERIVED

MeSH Terms

Interventions

Phacoemulsification

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Central Study Contacts

Wen Xu, PHD

CONTACT

+86 571 87783897xuwen2003@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2019

First Posted

July 5, 2019

Study Start

April 10, 2019

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

April 5, 2021

Record last verified: 2020-12

Locations

CN(1)