Trying a New Device for Performing Capsulorhexis in Cataract Surgery Surgery

NCT01396967 | Unknown Phase 1 DMC

• 1 other identifier: ZIV-0065-10
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

During cataract operations a capsulorhexis is being performed. This is done in order to enable the removal of lens material while keeping the capsule intact in order to put inside the lens capsule an artificial intra ocular lens. The capsulorhexis must be round and with regular edge and no tears. While performing a cataract surgery we use phako emulsification machine that sends an ultrasonic wave that creaks the lens nucleus and at the same time irrigates the anterior chamber of the eye and sucks the fluid and the lens material of the creaked lens. The round shape and the regularity of the capsulorhexis are a must in these surgeries since the lens capsule must stay intact and stable in order to enable the phacoemulsification and the implant of the artificial lens. Today capsulorhexis are done with a bent needle or with special forceps; the act of capsulorhexis is delicate, sometime un predicted and difficult to teach. The learning curve is relatively long and difficult. The proposed device enables a capsulorhexis which is round and has regular edges, done almost automatically and is predicted. The learning curve is short and easy. The capsulorhexis is done through the original operating wound with no need to widen it.

Conditions

Eye Disease; Cataract

Keywords

capsulorhexis

Outcome Measures

Primary Outcomes (1)

• capsulorhexis must be round and with regular edge and no tears

  As the title of this experiment:"The trying a new device for performing capsulorhexis in cataract surgery".Becuase we are not changing the protocol of Cataract surgery,the outcome measure of this experiment is the efficiency of this device, the safety and the simplicity of the use the device inorder to give a simple and safe solution for capsulorhexis.Therefor the outcome measure will be IOL stability, the shape of capsulorexis and intra ocular post operative inflammation if will occur. The trail is not comparative.

  Post operative follow up will be done as usually, one day, one week, 3 weeks and six weeks after operation

Interventions

surgery DEVICE

cataract surgery

Also known as: V.R.hexis-1

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• senile cataract

You may not qualify if:

• dens or mature cataract trauma congenital instability of the lens(phacodonesis,TXF)

Sponsors & Collaborators

• Ziv Hospital: lead

Study Sites (1)

Ziv Medical Center

Safed, Israel

Location

MeSH Terms

Conditions

Eye Diseases; Cataract

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Lens Diseases

Study Officials

• Joseph Pikkel, Md

  Ziv Medical Center Sefat Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 19, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 3, 2011

Record last verified: 2011-08

Locations

IL (1)