Trials Sponsors Conditions Drugs Pricing

Conditions

Cataract Corneal Disease

Keywords

cataractcorneakeratoplasty

Outcome Measures

Primary Outcomes (1)

Disposable contact lens successfully applied to the eye
Was the Contact Lens successfully applied to the eye? Yes or No.
Intraoperative (Day 0)

Secondary Outcomes (7)

Surgical evaluation of Corneal Incision
Intraoperative (Day 0)
Standard Outcomes Measurements
Pre-operative (Day -60 to Day -1)
Surgical evaluation of capsulotomy
Intraoperative (Day 0)
Surgical evaluation of fragmentation
Intraoperative (Day 0)
Standard outcomes measurement
1 week (5 to 10 days post operative)
+2 more secondary outcomes

Study Arms (1)

Treated

OTHER

This is a single arm study.

Device: LenSx Laser modified disposable contact lens

Interventions

LenSx Laser modified disposable contact lensDevice

Modified Disposable Contact Lens Patient Interface: Like the current disposable contact lens, a single unit is used for each procedure only once, and is then discarded. It is similarly mounted onto the distal end of the system's focusing objective and serves as a sterile barrier between the patient and the laser. In place of a separate suction ring that is used in the current contact lens, the modified contact lens has an integrated suction ring and curved applanation surface. These features result in significantly lower elevation of intraocular pressure and significantly easier application by the surgeon in preliminary testing. Identical to the current contact lens, the suction ring is applied around the patient's limbus and mild suction is applied to stabilize the eye.

Treated

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age24 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects must be eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye.
Subjects must be at least 24 years of age.

Sponsors & Collaborators

LenSx Lasers Inc.
Industrylead

Study Sites (1)

Slade and Baker Vision Center

Houston, Texas, 77027, United States

MeSH Terms

Conditions

CataractCorneal Diseases

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

Stephen Slade, MD
Slade and Baker Vision Center
PRINCIPAL INVESTIGATOR

Enrollment

110 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NA
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 11, 2010

Study Start

February 2010

Date type not reported

This date has not been verified as actual or estimated.

New Disposable Contact Lens Patient Interface For The Lensx Laser

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Treated

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Treated

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations