Clinical Evaluation of the Use of Sealed Capsule Irrigation With Sodium Chloride During Pediatric Cataract Surgery and IOL Implantation

NCT00366613 | Withdrawn Phase 4

• 1 other identifier: SEI-06-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study involves using both a device that seals the capsular bag (where the lens is located) allowing safer irrigation of the capsular bag and sodium chloride to irrigate the capsular bag during cataract surgery on children. The purpose of this study is to determine if the use of the device, Perfect Capsule, along with sodium chloride reduces the development of posterior capsule opacification (PCO), a possible complication of cataract surgery. PCO is the clouding of the rear portion of the natural membrane or capsule that holds the artificial lens. It requires additional procedures to correct the problem. Sodium chloride is not usually used during cataract surgery. It will be used to irrigate the capsular bag and remove any residual cells that contribute to the development of PCO. Perfect Capsule will prevent the sodium chloride from touching other parts of the eye. The goal of this study is to determine if irrigation with sodium chloride will lower the incidence of PCO after cataract surgery.

Conditions

Cataract Extraction

Keywords

Cataract; Cataract Extraction

Interventions

Cataract surgery with Perfect Capsule and Sodium Chloride PROCEDURE

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• bilateral cataract
• years of age
• Informed consent from the parents/legal guardian.

You may not qualify if:

• traumatic cataract
• fellow eye - visually not significant cataract
• fellow eye surgery not planned during the study enrollment period
• weak or compromised posterior or anterior capsule
• dense posterior capsule plaque
• preexisting posterior capsule defect
• capsulorhexis diameter\>5 mm
• radial capsular tears
• defects within the remaining capsular bag
• inability to visualize the entire capsulorhexis
• shallow anterior chamber
• very high vitreous pressure

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Storm Eye Institute, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction; Sodium Chloride

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Marion E Wilson, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 17, 2006
• First Posted: August 21, 2006
• Study Start: July 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: July 23, 2018

Record last verified: 2007-08

Locations

US (1)