Comparison of the Visual Quality of Traditional Ultrasound Biometrics and Lenstar on the Cataract After Pars Plana Vitrectomy (PPV)

April 1, 2018 updated by: Bojie Hu
Comparison of the visual quality of traditional ultrasound biometrics and lenstar on the cataract patients with diabetic retinopathy after vitrectomy in the 3 months later.To evaluate the clinical value of lenstar in post-vitrectomy patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

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
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Medical University Eye Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • yanhua He, master

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with cataract after vitrectomy because of diabetic retinopathy.

Description

Inclusion Criteria:

  1. Patients with cataract after vitrectomy because of diabetic retinopathy.
  2. Patients with good fixation in order to cooperate with various examination.

Exclusion Criteria:

  1. Myopia of >6 diopters
  2. Ocular trauma and other eye disease accepted vitrectomy,such as branch retinal vein occlusion(BRVO),central retinal vein occlusion(CRVO).
  3. Vision acuity <0.1
  4. Silicone oil eye

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group:Traditional ultrasonic biological
The measurement of axial length was performed in 60 eyes (30 eyes for each group) with senile cataract of vitrectomised eye of diabetic retinopathy using lenstar and traditional ultrasonic biological combined with cornea curvimeter.In this group,we use traditional ultrasonic biological combined with cornea curvimeter to measure the ocular parameter.
Device: Traditional ultrasound biometrics
To evaluate the clinical feasibility of using a new optical coherence interferometry ( lenstar ),comparing with traditional ultrasonic biometry and keratometry in the accuracy and characteristics for intraocular lens calculation of cataract after PPV
Group:Lenstar
The measurement of axial length was performed in 60 eyes (30 eyes for each group) with senile cataract of vitrectomised eye of diabetic retinopathy using lenstar and traditional ultrasonic biological combined with cornea curvimeter.In this group,we use lenstar to measure the ocular parameter.
Device: Lenstar
To evaluate the clinical feasibility of using a new optical coherence interferometry ( lenstar ),comparing with traditional ultrasonic biometry and keratometry in the accuracy and characteristics for intraocular lens calculation of cataract after PPV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the visual quality of the eye after surgery
Time Frame: one month
the visual quality of the eye after surgery through optical path difference scan（OPD Scan）
one month
the visual quality of the eye after surgery
Time Frame: three month
the visual quality of the eye after surgery through optical path difference scan（OPD Scan）
three month

Collaborators and Investigators

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

Sponsor

Bojie Hu

Investigators

  • Study Director: bojie Hu, docter, Tianjin Medical University Eye Hospital

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 (Anticipated)

April 3, 2018

Primary Completion (Anticipated)

July 31, 2018

Study Completion (Anticipated)

October 31, 2018

Study Registration Dates

First Submitted

March 24, 2018

First Submitted That Met QC Criteria

March 30, 2018

First Posted (Actual)

April 2, 2018

Study Record Updates

Last Update Posted (Actual)

April 3, 2018

Last Update Submitted That Met QC Criteria

April 1, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBJ 161718

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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