Dysfunctional Lens Index Serves as a Novel Surgery Decision Maker for Age-related Cataracts

Age-related Cataract Clinical Trial

Official title:

Dysfunctional Lens Index Serves as a Novel Surgery Decision Maker for Age-related Cataracts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03340389
• Other study ID #: DLI_HZ
• 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
• 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.

Related Conditions & MeSH terms

• Age-related Cataract
• Cataract

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