NCT01647373

Brief Summary

All existing medical literatue regarding axial length (AL) changes after scleral buckling surgery for retinal detachment, descibes changes after solid silicone buckling. In this hospital, the investigators use only silicone sponge buckling, which has different properties and a different buckle profile. there are no studies in the literature describing tha AL changes after sponge buckling, or whether the AL change is less or more than with solid silicone buckles. The investigators wish to determine whether the AL change profile with their silicone sponge is significantly different, and if so, whether this is clinically important in determining the better choice of buckle material to be preferred.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

June 12, 2013

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

July 19, 2012

Last Update Submit

June 11, 2013

Conditions

Keywords

retinal detachmentscleral bucklesilicone spongeaxial lengthsurgery included silicone sponge scleral bucklingretina currently attachedat least 6 months after surgery

Outcome Measures

Primary Outcomes (1)

  • Axial length in eye as measured by Zeiss IOL Master.

    Single non-invasive measurement at 1 time point.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients at least 6 months after succesful retinal detachment surgery, with silicone sponge scleral buckling, currently attached, and with IOL Master pre-surgery Axial Length measurement .

You may qualify if:

  • Patients at least 6 months after succesful retinal detachment surgery
  • with silicone sponge scleral buckling
  • currently attached
  • with IOL Master pre-surgery Axial Length measurement

You may not qualify if:

  • patients with failed surgery and currently detached
  • patients with vitreos silicone oil tamponade
  • patients with radial or other non-circumference buckles
  • patients with unclear media not amenable to IOL Master exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Meir hospital, dept. Of ophthalmology

Kfar Saba, Israel

Location

Retina Service, Meir Hospital

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Alex Rubowitz, MD

    Retina Service, Meir Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Rubowitz, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2012

First Posted

July 23, 2012

Study Start

July 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 12, 2013

Record last verified: 2012-07

Locations