HyperopiaNCT00762281
Safety and Effectiveness Study of the MEL 80 Excimer Laser Using LASIK in the Treatment of Hyperopia
A study testing MEL 80 Hyperopic LASIK Treatment in people with Hyperopia, run by Carl Zeiss Meditec, Inc. at 6 sites in United States.
Trial summary
The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in the treatment of hyperopia, when used as part of the Laser In Situ Keratomileusis (LASIK) procedure. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperopia
- What is being tested?
- MEL 80 Hyperopic LASIK Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2004to Oct 2008
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Naturally occurring hyperopia up to +6.0 D, with or without astigmatism of +0.50 D to +3.50 D at the spectacle plane, and MRSE ≤ +6.50 D;
- Have ≤ 0.75 D of latent hyperopia as determined by the difference between the preoperative MRSE and CRSE;
- A stable refraction for at least the last 12 months as documented by previous clinical records, i.e., the spherical and cylindrical portions of the manifest refraction have not progressed at a rate of more than 0.50 D during the year prior to the baseline examination in the eye to be treated;
- 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;
- Visual acuity correctable to at least 20/40 in both eyes;
- Operative eye must be targeted for emmetropia;
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- At least 21 years of age;
- Willing and able to return for scheduled follow up examinations for 24 months after surgery;
- Sign and be given a copy of the written Informed Consent form.
Who cannot join
- A history of anterior segment pathology, including cataracts (in the operative eye);
- Severe 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);
- An ablation 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;
- Undergone previous intraocular or corneal surgery of any kind in the operative eye(s), including any type of excimer laser surgery for either refractive or therapeutic purposes;
- A history of ocular Herpes zoster or Herpes simplex keratitis;
- A 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 or use chronic systemic corticosteroid or other immunosuppressive therapy;
- Pregnant, lactating, or be of childbearing potential and not practicing a medically approved method of birth control;
- A known sensitivity to planned study medications;
- Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
- At risk for angle closure or for developing strabismus postoperatively.
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Texan Eye Care
Austin, Texas, 78746
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
About this study
Official title: A Prospective, Randomized, Multicenter Trial To Evaluate The Safety And Effectiveness Of The MEL 80 Excimer Laser Using LASIK (Laser In Situ Keratomileusis) For The Correction Of ≤ +6.0 D Of Hyperopia With Or Without Astigmatism Of +0.50 D To +3.50 D And MRSE ≤ +6.50 D
The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in the treatment of hyperopia, when used as part of the Laser In Situ Keratomileusis (LASIK) procedure.
Read the detailed description
LASIK has become one of the most common refractive eye procedures performed in the country. In the hyperopia procedure, a steepening occurs on the corneal surface, rather than the flattening procedure (myopic treatment). 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 hyperopic refractive correction results.
- Conditions
- Hyperopia
- Being tested
- MEL 80 Hyperopic LASIK Treatment
- Keywords
- Hyperopia, Laser In Situ Keratomileusis, Laser Therapy, Laser Corneal Surgery, Refractive Surgical Procedures, Ophthalmologic Surgical Procedure, Operative Surgical Procedures, Therapeutics
- Medical subject headings
- Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEL 80 Hyperopic LASIK TreatmentDevice
Treatment of Hyperopic corrections ≤ +6.0 D with or without Astigmatism of +0.50 to +3.50 D and MRSE ≤ +6.50 D.
| Study group | Role | What they receive |
|---|---|---|
| Treatment of Hyperopic LASIK | Other | Treatment of Hyperopic corrections ≤ +6.0 D with or without Astigmatism of +0.50 to +3.50 D and MRSE ≤ +6.50 D. Receives: Device: MEL 80 Hyperopic LASIK Treatment |
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 targeted for emmetropia 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
75% of eyes undergoing astigmatic treatment should be within ± 1.00 D of the attempted astigmatism correction by the point of stability.
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: Point of stability
Less than 5% of eyes treated for sphere only should have a magnitude of postoperative manifest refractive astigmatism that varies from baseline cylinder by greater than 2.00 D at the postoperative interval at which stability has been established.
Measured: Point of stability
Incidence of Adverse Events to occur in less 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, 12, 18 and 24 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, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startJul 2004
- Primary completionOct 2006
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperopiaStudies 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
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Dell, MD, Principal investigator, Texan Eye CareJohn Doane, MD, Principal investigator, Discover Vision CentersRichard Hoffman, MD, Principal investigator, Fine, Hoffman, and Packer LLCHoward Fine, MD, Principal investigator, Fine, Hoffman, and Packer LLCMark Packer, MD, Principal investigator, FIne, Hoffman, and Packer LLCDavid Tanzer, MD, Principal investigator, US Navy Refractive Surgery Center, San Diego, CASteve Schallhorn, MD, Principal investigator, US Navy Refractive Surgery Center, San Diego, CAJohn Vukich, MD, Principal investigator, Davis Duehr Dean Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762281
- Sponsor's protocol ID
- MEL 80-2004-2
- Status last verified
- Aug 2012
- First submitted
- 26 Sep 2008
- Last updated
- 13 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Trial To Evaluate The Safety And Effectiveness Of The MEL 80 Excimer Laser Using LASIK (Laser In Situ Keratomileusis) For The Correction Of ≤ +6.0 D Of Hyperopia With Or Without Astigmatism Of +0.50 D To +3.50 D And MRSE ≤ +6.50 D
- ClinicalTrials.gov ID
- NCT00762281
- Acronym / sponsor ID
- MEL 80-2004-2
- Conditions
- Hyperopia
- Keywords
- Hyperopia, 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
- 189 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2008 (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.
The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in the treatment of hyperopia, when used as part of the Laser In Situ Keratomileusis (LASIK) procedure.
Detailed description
LASIK has become one of the most common refractive eye procedures performed in the country. In the hyperopia procedure, a steepening occurs on the corneal surface, rather than the flattening procedure (myopic treatment). 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 hyperopic refractive correction results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of Hyperopic LASIK | Other | Device: MEL 80 Hyperopic LASIK TreatmentTreatment of Hyperopic corrections ≤ +6.0 D with or without Astigmatism of +0.50 to +3.50 D and MRSE ≤ +6.50 D. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Naturally occurring hyperopia up to +6.0 D, with or without astigmatism of +0.50 D to +3.50 D at the spectacle plane, and MRSE ≤ +6.50 D;
- Have ≤ 0.75 D of latent hyperopia as determined by the difference between the preoperative MRSE and CRSE;
- A stable refraction for at least the last 12 months as documented by previous clinical records, i.e., the spherical and cylindrical portions of the manifest refraction have not progressed at a rate of more than 0.50 D during the year prior to the baseline examination in the eye to be treated;
- 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;
- Visual acuity correctable to at least 20/40 in both eyes;
Key exclusion criteria (22 listed)
- A history of anterior segment pathology, including cataracts (in the operative eye);
- Severe 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);
- An ablation 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 Hyperopic LASIK TreatmentTreatment of Hyperopic corrections ≤ +6.0 D with or without Astigmatism of +0.50 to +3.50 D and MRSE ≤ +6.50 D. | Device | Treatment of Hyperopic LASIK |
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 targeted for emmetropia 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
75% of eyes undergoing astigmatic treatment should be within ± 1.00 D of the attempted astigmatism correction by the point of stability.
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: Point of stability
Less than 5% of eyes treated for sphere only should have a magnitude of postoperative manifest refractive astigmatism that varies from baseline cylinder by greater than 2.00 D at the postoperative interval at which stability has been established.
Time frame: Point of stability
Incidence of Adverse Events to occur in less 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, 12, 18 and 24 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, 12, 18 and 24 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 13 Aug 2012.
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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.
Steven Dell, MD principal investigator
Texan Eye Care
John Doane, MD principal investigator
Discover Vision Centers
Richard Hoffman, MD principal investigator
Fine, Hoffman, and Packer LLC
6 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 Hyperopic LASIK Treatment in people with Hyperopia, run by Carl Zeiss Meditec, Inc. at 6 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 9 inclusion and 22 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 13 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2012.