Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling

Rhegmatogenous Retinal Detachment Clinical Trial

Official title:

Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01647373
• Other study ID #: 0125-12
• Status: Not yet recruiting
• Phase: N/A
• First received: July 19, 2012
• Last updated: June 11, 2013
• Start date: July 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2012
• Source: Meir Medical Center
• Contact: Alexander Rubowitz, MD
• Phone: 972-9-7472772
• Email: arubowi[@]smile.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Retinal Detachment
• Rhegmatogenous Retinal Detachment

Locations

Country	Name	City	State
Israel	Meir hospital, dept. Of ophthalmology	Kfar Saba
Israel	Retina Service, Meir Hospital	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial length in eye as measured by Zeiss IOL Master.		Single non-invasive measurement at 1 time point.	No