Mixed AstigmatismNCT00761826

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

A study testing MEL 80 Mixed Astigmatism Treatment in people with Mixed Astigmatism, run by Carl Zeiss Meditec, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in the treatment of mixed astigmatism up to 6.0 D, when used as part of the Laser In Situ Keratomileusis (LASIK) procedure. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Mixed Astigmatism
What is being tested?: MEL 80 Mixed Astigmatism Treatment
Type of treatment: Medical device
How many people: 126 participants
Where: 5 sitesUnited States
Study dates: Jan 2007to Dec 2009
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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;
Discontinue use of contact lenses at least 2 weeks for hard contacts and 3 days for soft lenses prior to the preoperative examination;
Hard contact lens wearers must have two central keratometry readings and two manifest refractions taken at least one week apart that do not differ by more than 0.50 D
Have visual acuity correctable to at least 20/40 in both eyes
Have no more than 0.75 D of latent hyperopia as determined by the difference between the preoperative manifest refractive spherical equivalent (MRSE) and cycloplegic refractive spherical equivalent (CRSE);

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Be at least 18 years of age
Corneal topography should be normal;
The operative eye must be targeted for emmetropia;
Be willing and able to return for scheduled follow-up examinations for twelve months after surgery;
and provide written informed consent.

Who cannot join

History of anterior segment pathology, including cataracts (in the operative eye);
Clinically significant dry eye syndrome unresolved by treatment;
Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars within the ablation zone or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease;
Ophthalmoscopic signs of keratoconus (or keratoconus suspect);
Required ablation is deeper than 250 microns from the corneal endothelium;
Irregular or unstable (distorted/not clear) corneal mires on central keratometry readings;

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Blind in the fellow eye;
Previous intraocular or corneal surgery of any kind in the operative eye(s), including any type of surgery for either refractive or therapeutic purposes;
History of ocular Herpes zoster or Herpes simplex keratitis;
History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP >21 mm Hg;
Diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome;
Immunocompromised patients, or use of chronic systemic corticosteroid or other immunosuppressive therapy;
Pregnant, lactating, or child-bearing potential and not practicing a medically approved method of birth control;
Sensitivity to planned study medications;
Simultaneous participation in other ophthalmic drug or device clinical trial.
For Fellow (Second) Eyes in Simultaneous Bilateral Treatment Procedures
1. Flap complications during the first eye's surgery such as a free cap, partial flap, thin flap, or irregular flap.
2. Epithelial defect exceeding 2 mm x 2 mm in dimension, or clinically significant debris in the interface between the flap and underlying stroma for the first eye.
3. Severe blepharospasm in the first eye that may have prevented or impeded the completion of the keratectomy and/or the laser ablation procedure.
4. Poor subject cooperation with instructions for the first eye's surgery and/or poor subject fixation on the laser fixation target.
5. Aborted LASIK procedure in the first eye or PRK was performed in the first eye because LASIK was not possible.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Fine, Hoffman, and Packer
Eugene, Oregon, 97401
Dishler Laser Institute
Greenwood Village, Colorado, 80111
Discover Vision Centers
Kansas City, Missouri, 64055
Davis Duehr Dean Eye Clinic
Madison, Wisconsin, 53717
US Navy Refractive Surgery Center
San Diego, California, 92106

Other trials in United States

About this study

Official title: A Prospective Multicenter Trial To Evaluate The Safety And Effectiveness Of The MEL 80 Excimer Laser Using LASIK (Laser In Situ Keratomileusis) For The Correction Of Naturally Occuring Mixed Astigmatism Up To 6.0 D

Read the detailed description

LASIK has become one of the most common refractive eye procedures performed in the country. In the mixed astigmatism procedure, a combination of both a steepening (hyperopic treatment) and a flattening (myopic treatment) occur on the corneal surface. The surgeon will produce a standard keratomileusis flap using a microkeratome, exposing the corneal stroma. Recontouring under the flap is then accomplished by the removal of tissue from the stroma with the laser. This recontouring results in an altering of effective lens power of the central cornea, measured in diopters (D). The MEL 80 Excimer Laser System will be evaluated for its ability to create accurate and stable mixed astigmatic refractive correction results.

Conditions: Mixed Astigmatism
Being tested: MEL 80 Mixed Astigmatism Treatment
Keywords: Mixed Astigmatism, Laser In Situ Keratomileusis, Laser Therapy, Laser Corneal Surgery, Refractive Surgical Procedures, Ophthalmologic Surgical Procedure, Operative Surgical Procedures, Therapeutics
Medical subject headings: Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MEL 80 Mixed Astigmatism TreatmentDevice
Treatment of Naturally Occuring Mixed Astigmatic corrections up to 6.0 D.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Point of stability
Loss of more than 2 lines of BSCVA should occur in less than 5.0 % of eyes.
Measured: Postoperative visits
Incidence of adverse events to occur in less than 1% of eyes
Measured: Postoperative visits

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Dec 2009

First posted30 Sep 2008 (estimated)
Study startJan 2007
Primary completionDec 2008
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Mixed AstigmatismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00761826
Sponsor's protocol ID: MEL 80-2006-2
Status last verified: Jan 2018
First submitted: 26 Sep 2008
Last updated: 19 Jul 2018
Results posted: No
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Multicenter Trial To Evaluate The Safety And Effectiveness Of The MEL 80 Excimer Laser Using LASIK (Laser In Situ Keratomileusis) For The Correction Of Naturally Occuring Mixed Astigmatism Up To 6.0 D
ClinicalTrials.gov ID: NCT00761826
Acronym / sponsor ID: MEL 80-2006-2
Conditions: Mixed Astigmatism
Keywords: Mixed Astigmatism, Laser In Situ Keratomileusis, Laser Therapy, Laser Corneal Surgery, Refractive Surgical Procedures, Ophthalmologic Surgical Procedure, Operative Surgical Procedures, Therapeutics
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Carl Zeiss Meditec, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Dec 2008 (actual)
Study completion: Dec 2009 (actual)
First posted: 30 Sep 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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;
Discontinue use of contact lenses at least 2 weeks for hard contacts and 3 days for soft lenses prior to the preoperative examination;
Hard contact lens wearers must have two central keratometry readings and two manifest refractions taken at least one week apart that do not differ by more than 0.50 D
Have visual acuity correctable to at least 20/40 in both eyes

Key exclusion criteria (21 listed)

History of anterior segment pathology, including cataracts (in the operative eye);
Clinically significant dry eye syndrome unresolved by treatment;
Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars within the ablation zone or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease;
Ophthalmoscopic signs of keratoconus (or keratoconus suspect);
Required ablation is deeper than 250 microns from the corneal endothelium;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MEL 80 Mixed Astigmatism TreatmentTreatment of Naturally Occuring Mixed Astigmatic corrections up to 6.0 D.	Device	–

Primary outcome

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Point of stability
Loss of more than 2 lines of BSCVA should occur in less than 5.0 % of eyes.
Time frame: Postoperative visits
Incidence of adverse events to occur in less than 1% of eyes
Time frame: Postoperative visits

3 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Doane, MD principal investigator

Discover Vision Centers

Richard Hoffman, MD principal investigator

Fine, Hoffman, and Packer LLC

Howard Fine, MD principal investigator

Fine, Hoffman, and Packer LLC

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MEL 80 Mixed Astigmatism Treatment in people with Mixed Astigmatism, run by Carl Zeiss Meditec, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Point of stability). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00761826.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.