NCT02783209

Brief Summary

This study evaluates the association between surgery of the cataract and posterior vitreous detachment, in the emmetropic patient, by comparing eyes operated with eyes not operated in the same group of patients

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

3.2 years

First QC Date

May 12, 2016

Last Update Submit

February 1, 2018

Conditions

CataractVitreous Detachment

Outcome Measures

Primary Outcomes (1)

  • Occurence of vitreous detachment in the operated eye

    3 months after the cataract surgery

Study Arms (1)

Cataract surgery

OTHER

Patient acts as his own control

Procedure: Cataract surgery

Interventions

Cataract surgeryPROCEDURE
Cataract surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult emmetropic patient
  • Without complete posterior vitreus detachment in both eyes before having surgery.

You may not qualify if:

  • Diabetic retinopathy
  • Ophthalmological treatment in progress
  • History of ophthalmological surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

URC Fondation Ophtalmologique A de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

CataractVitreous Detachment

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 26, 2016

Study Start

December 1, 2014

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

FR(1)