Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

Mixed AstigmatismLaser In Situ KeratomileusisLaser TherapyLaser Corneal SurgeryRefractive Surgical ProceduresOphthalmologic Surgical ProcedureOperative Surgical ProceduresTherapeutics

Outcome Measures

Primary Outcomes (6)

At the point of stability, a minimum of 75% of eyes should have an achieved refraction within ± 1.00 D of the intended outcome, and at least 50% of eyes should be within ± 0.50 D of the intended outcome.
Point of stability
A minimum of 85% of eyes should have an uncorrected visual acuity of 20/40 or better at the postoperative interval at which stability has been established.
Point of stability
A minimum of 95% of eyes should have a change of < 1.00 D in manifest refraction spherical equivalent (MRSE) between 2 refractions performed at least 3 months apart, and the mean rate of MRSE change per month should be < 0.04 D.
Point of stability
Distance BSCVA of worse than 20/40 at the postoperative interval at which stability has been established should occur in less than 1.0 % of eyes that had a BSCVA of 20/20 or better before surgery.
Point of stability

Secondary Outcomes (3)

Subject Satisfaction: As measured by a subjective questionnaire, and will be considered as a secondary efficacy variable.
Postoperative visits 3, 6, 9 and 12 months
Incidence of complications
Postoperative visits
Patient Symptoms: As measured by a subjective questionnaire, will be considered as a secondary safety variable.
Preoperative and Postoperative visits 3, 6, 9 and 12 months

Interventions

MEL 80 Mixed Astigmatism TreatmentDevice

Treatment of Naturally Occuring Mixed Astigmatic corrections up to 6.0 D.

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

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

You may qualify if:

Naturally occurring mixed astigmatism when the magnitude of cylinder (up to 6.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs, at the spectacle plane;
Have a stable refraction for at least the past twelve months, as demonstrated by a change of less than or equal to 0.50 D preoperative spherical equivalent shift over twelve months prior to surgery;

Sponsors & Collaborators

Carl Zeiss Meditec, Inc.
Industrylead

Study Sites (5)

US Navy Refractive Surgery Center

San Diego, California, 92106, United States

Dishler Laser Institute

Greenwood Village, Colorado, 80111, United States

Discover Vision Centers

Kansas City, Missouri, 64055, United States

Fine, Hoffman, and Packer

Eugene, Oregon, 97401, United States

Davis Duehr Dean Eye Clinic

Madison, Wisconsin, 53717, United States

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

John Doane, MD
Discover Vision Centers
PRINCIPAL INVESTIGATOR
Richard Hoffman, MD
Fine, Hoffman, and Packer LLC
PRINCIPAL INVESTIGATOR
Howard Fine, MD
Fine, Hoffman, and Packer LLC
PRINCIPAL INVESTIGATOR
Mark Packer, MD
FIne, Hoffman, and Packer LLC
PRINCIPAL INVESTIGATOR

Enrollment

126 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 30, 2008

Study Start

January 2007

Date type not reported

This date has not been verified as actual or estimated.

Study of the MEL 80 Excimer Laser Using LASIK in the Treatment of Mixed Astigmatism

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

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 (6)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations