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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03485586
Other study ID # HBJ 161718
Secondary ID
Status Recruiting
Phase
First received March 24, 2018
Last updated April 1, 2018
Start date April 3, 2018
Est. completion date October 31, 2018

Study information

Verified date April 2018
Source Tianjin Medical University Eye Hospital
Contact bojie Hu, docter
Phone 13612130943
Email hbj151617@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 31, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
China Tianjin Medical University Eye Hospital Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Bojie Hu

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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