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

Sponsor
Bojie Hu (Other)
Overall Status
Unknown status
CT.gov ID
NCT03485586
Collaborator
(none)
60
1
6.9
8.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Traditional ultrasound biometrics
  • Device: Lenstar

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Comparison of the Visual Quality of Traditional Ultrasound Biometrics and Lenstar on the Cataract After Pars Plana Vitrectomy
Anticipated Study Start Date :
Apr 3, 2018
Anticipated Primary Completion Date :
Jul 31, 2018
Anticipated Study Completion Date :
Oct 31, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. the visual quality of the eye after surgery [one month]

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

  2. the visual quality of the eye after surgery [three month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tianjin Medical University Eye Hospital Tianjin Tianjin China

Sponsors and Collaborators

  • Bojie Hu

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bojie Hu, Bojie Hu, Head of Ophthalmology department, Principal Investigator, Associate Senior Physician, Tianjin Medical University Eye Hospita, Tianjin Medical University Eye Hospital
ClinicalTrials.gov Identifier:
NCT03485586
Other Study ID Numbers:
  • HBJ 161718
First Posted:
Apr 2, 2018
Last Update Posted:
Apr 3, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bojie Hu, Bojie Hu, Head of Ophthalmology department, Principal Investigator, Associate Senior Physician, Tianjin Medical University Eye Hospita, Tianjin Medical University Eye Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 3, 2018