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

NCT ID: NCT03340389

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Age-related Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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cataract surgery

cataract extraction and intraocular implantation

Group Type EXPERIMENTAL

a ray-tracing aberrometry

Intervention Type PROCEDURE

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

Interventions

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a ray-tracing aberrometry

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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yin ying zhao

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhangliang Li, MD

Role: CONTACT

Phone: +86-571-88185666

Email: [email protected]

Facility Contacts

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zhao Yinying, PhD

Role: primary

Other Identifiers

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DLI_HZ

Identifier Type: -

Identifier Source: org_study_id