NCT03485586

Brief Summary

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.

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 all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

April 3, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

April 3, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

March 24, 2018

Last Update Submit

April 1, 2018

Conditions

Keywords

cataract, higher order aberration,vitrectomy,diabetic retinopathy

Outcome Measures

Primary Outcomes (2)

  • the visual quality of the eye after surgery

    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

    the visual quality of the eye after surgery through optical path difference scan(OPD Scan)

    three month

Study Arms (2)

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

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

Interventions

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:Traditional ultrasonic biological
LenstarDEVICE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with cataract after vitrectomy because of diabetic retinopathy.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • bojie Hu, docter

    Tianjin Medical University Eye Hospital

    STUDY DIRECTOR

Central Study Contacts

bojie Hu, docter

CONTACT

yanhua He, master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Bojie Hu, Head of Ophthalmology department, Principal Investigator, Associate Senior Physician, Tianjin Medical University Eye Hospita

Study Record Dates

First Submitted

March 24, 2018

First Posted

April 2, 2018

Study Start

April 3, 2018

Primary Completion

July 31, 2018

Study Completion

October 31, 2018

Last Updated

April 3, 2018

Record last verified: 2018-04

Locations