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

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ClinicalTrials.gov Identifier: NCT03485586
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Bojie Hu, Tianjin Medical University Eye Hospital

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
Diabetic Retinopathy Patients After Vitrectomy Device: Traditional ultrasound biometrics Device: Lenstar

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Study Type : Observational
Estimated 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
Estimated Study Start Date : April 3, 2018
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)

  2. 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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with cataract after vitrectomy because of diabetic retinopathy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485586


Contacts
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Contact: bojie Hu, docter 13612130943 hbj151617@163.com
Contact: yanhua He, master 13920555905 heyanhua0104@163.com

Locations
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China, Tianjin
Tianjin Medical University Eye Hospital Recruiting
Tianjin, Tianjin, China
Contact: bojie HU, docter    13612130943    hbj151617@163.com   
Contact: yanhua He, master    13920555905    heyanhua0104@163.com   
Principal Investigator: yanhua He, master         
Sponsors and Collaborators
Bojie Hu
Investigators
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Study Director: bojie Hu, docter Tianjin Medical University Eye Hospital

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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     History of Changes
Other Study ID Numbers: HBJ 161718
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bojie Hu, Tianjin Medical University Eye Hospital:
cataract, higher order aberration,vitrectomy,diabetic retinopathy

Additional relevant MeSH terms:
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Cataract
Retinal Diseases
Diabetic Retinopathy
Capsule Opacification
Lens Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases