Clinical Observation of the Transscleral Suture Fixation of Posterior Chamber Intraocular Lens in Eyes With Inadequate Capsule Support

January 24, 2019 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Clinical Observation of Transscleral Suture Fixation of Posterior Chamber Intraocular Lens in Eyes With Inadequate Capsule Support

To present the follow-up outcomes of transscleral suture fixation of posterior chamber intraocular lens (PCIOL) in eyes with inadequate capsule support.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21

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
        • Second Affiliated Hospital, Zhejiang University School of Medicine

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

10 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent transscleral sutured PCIOL implantation between January 2017 and August 2018, in Eye Center of the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.

Description

Inclusion Criteria:

  1. Patients who underwent transscleral suture fixation of PCIOL
  2. Time between the primary surgeries was at least 3 months

Exclusion Criteria:

  1. Active intraocular inflammation
  2. The intraocular pressure (IOP) was higher than 25 mmHg
  3. The endothelial cell count (ECC) was more than 1,200 cells/mm2

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual function
Time Frame: 1day postoperation
Best corrected visual acuity (BCVA) measured using a decimal chart
1day postoperation
Visual function
Time Frame: 1 week postoperation
Best corrected visual acuity (BCVA) measured using a decimal chart
1 week postoperation
Visual function
Time Frame: 1 month postoperation
Best corrected visual acuity (BCVA) measured using a decimal chart
1 month postoperation
Visual function
Time Frame: 3 month postoperation
Best corrected visual acuity (BCVA) measured using a decimal chart
3 month postoperation
Visual function
Time Frame: 1 day postoperation
uncorrected distance visual acuity (UDVA) measured using a decimal chart
1 day postoperation
Visual function
Time Frame: 1 week postoperation
uncorrected distance visual acuity (UDVA) measured using a decimal chart
1 week postoperation
Visual function
Time Frame: 1 month postoperation
uncorrected distance visual acuity (UDVA) measured using a decimal chart
1 month postoperation
Visual function
Time Frame: 3 month postoperation
uncorrected distance visual acuity (UDVA) measured using a decimal chart
3 month postoperation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraocular pressure
Time Frame: 1 day, 1 week, 1 month, and 3 month postoperation
intraocular pressure
1 day, 1 week, 1 month, and 3 month postoperation
endothelial cell count
Time Frame: 1 week, 1 month, and 3 month postoperation
endothelial cell count
1 week, 1 month, and 3 month postoperation
PCIOL tilt degree
Time Frame: 3 month postoperation
PCIOL tilt degree measured using Ultrasound biomicroscope
3 month postoperation
PCIOL decentration degree
Time Frame: 3 month postoperation
PCIOL tilt degree measured using Ultrasound biomicroscope
3 month postoperation
anterior chamber depth
Time Frame: 3 month postoperation
anterior chamber depth measured using Ultrasound biomicroscope
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

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)

January 1, 2017

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 25, 2019

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xuwen2017-022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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