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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03340389
Other study ID # DLI_HZ
Secondary ID
Status Recruiting
Phase N/A
First received November 6, 2017
Last updated November 8, 2017
Start date September 1, 2017
Est. completion date December 1, 2018

Study information

Verified date November 2017
Source Wenzhou Medical University
Contact Zhangliang Li, MD
Phone +86-571-88185666
Email lizhangliang0328@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To study the correlations among the dysfunctional lens index (DLI), Lens Opacities Classification System III (LOCS III) nuclear opalescence grading score, preoperative corrected distance visual acuity (CDVA), the objective scatter index (OSI) and Scheimpflug based average lens density in age-related cataracts. To investigate the potential of the DLI as a novel surgery decision maker via the Operating Characteristic (ROC) curve analysis.


Description:

Each patient received a comprehensive eye examination, including corrected distance visual acuity (CDVA) preoperatively and the day after surgery, subjective refraction, slit-lamp evaluation, noncontact tonometry (TX-F; Cannon, Tokyo, Japan), and dilated fundus examination. According to the surgery decision made by the three surgeons based on the slit lamp biomicroscopy and CDVA, patients were divided into two groups: Surgical and Non-Surgical. The results of the DLI, OSI and average lens density (ALD) were masked to the surgeons. The DLI, OSI, average lens density, LOCS III nuclear opalescence grading, and preoperative CDVA were obtained. Correlations among these parameters were analyzed. ROC curves were used to analyze DLI values to determine a value to separate between surgical and non-surgical cataracts.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- patients with age-related cataracts

Exclusion Criteria:

- any corneal opacity, corneal dystrophies, retinal anomalies, a history of ocular surgery or laser treatment, a LOCS III grade of cortical opacity = 3.0 or posterior subcapsular cataract = 2.0.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
a ray-tracing aberrometry
The Dysfunctional Lens Index is obtained by a ray-tracing aberrometry

Locations

Country Name City State
China Eye Hospital of Wenzhou Medical College Wenzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dysfunctional lens index The DLI is an objective lens performance metric derived from internal higher order aberrations (HOAs), pupil size, and contrast sensitivity data 6 months
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