NCT03340389

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

8 months

First QC Date

November 6, 2017

Last Update Submit

November 8, 2017

Conditions

Age-related Cataract

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

cataract surgery

EXPERIMENTAL

cataract extraction and intraocular implantation

Procedure: a ray-tracing aberrometry

Interventions

a ray-tracing aberrometryPROCEDURE

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

cataract surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with age-related cataracts

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

RECRUITING

Central Study Contacts

Zhangliang Li, MD

CONTACT

+86-571-88185666lizhangliang0328@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 6, 2017

First Posted

November 13, 2017

Study Start

September 1, 2017

Primary Completion

May 1, 2018

Study Completion

December 1, 2018

Last Updated

November 13, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)