The Berkeley Orthokeratology Study
|First Received Date ICMJE||September 23, 1999|
|Last Updated Date||September 16, 2009|
|Start Date ICMJE||January 1978|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00000123 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Berkeley Orthokeratology Study|
|Official Title ICMJE||Not Provided|
To evaluate the relative efficacy of orthokeratology, primarily by assessment of changes in central corneal thickness, astigmatism, visual acuity, endothelial cell density, and corneal curvature.
To evaluate the relative safety of orthokeratology, primarily by assessment of changes in central corneal thickness, astigmatism, visual acuity, endothelial cell density, induced corneal edema, and epithelial staining.
To assess the duration of any orthokeratology treatment effect.
To study the mechanisms by which refractive error and visual acuity changes occur, in particular the contribution that comes from changes in corneal curvature and shape.
To determine whether there were any predisposing ocular factors that could be used to predict which subjects will experience changes or complications.
In the early 1960s, a group of clinicians asserted that myopia could be reduced and possibly corrected by fitting specially designed contact lenses to induce corneal flattening and thereby reduce the refractive power of the eye. This technique, known as orthokeratology, required that the lenses be fitted and then changed progressively until vision becomes normal or nearly normal. Advocates of orthokeratology claimed that corneal changes could be induced in a predictable fashion, were often permanent, and occurred without causing any adverse effects to the cornea. Data on orthokeratology were generally limited, poorly documented, and did not address the issues of control or failure.
The Berkeley Orthokeratology Study was a single center randomized, concurrently controlled, masked clinical trial. Corneal and visual changes in an orthokeratology treatment group were monitored and compared with those observed in a control group whose members wore contact lenses fitted in a standard clinical manner. Visual and ocular characteristics were monitored for 1.5 years.
Eighty subjects were studied-40 in an orthokeratology group and 40 in a control group fitted with conventional hard contact lenses. The hard lenses chosen for this study were made of either polymethyl methacrylate (PMMA) or a PMMA-silicone combination (Polycon). All subjects were initially fitted with PMMA lenses.
The initial treatment and control lenses were selected according to protocol guidelines and then adjusted to achieve an "optimal fit" based on lens position, movement, and alignment as assessed by fluorescein study. At the outset, the treatment and control lenses differed in that the treatment lenses were on the average thicker and flatter and had a larger diameter.
Following the dispensing visit, subjects progressed through three study phases. In the adaption phase (Phase A), subjects were examined weekly until they were adapted to 12 to 14 hours of daily contact lens wear. The postadaptive phase (Phase B) consisted of monthly followup examinations for 1 year. The final phase (Phase C) consisted of a lens withdrawal segment and a postwearing segment.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||February 1979|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||Myopic volunteers, ages 20 to 35, who had not worn contact lenses were eligible to participate in the study if they were free of ocular disease, were in good physical health, and were not taking systemic medications that could have ocular side effects. In addition, eligibility was limited to persons with corneal curvature between 40.50 and 47.00 D (flatter keratometry reading), corrected visual acuity of 6/6 (20/20) or better in each eye, astigmatism less than 0.75 D, anisometropia less than 1 D, and myopia between 1 and 4 D.|
|Ages||20 Years to 35 Years|
|Accepts Healthy Volunteers||Not Provided|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT00000123|
|Other Study ID Numbers ICMJE||NEI-22|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Eye Institute (NEI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Eye Institute (NEI)|
|Verification Date||September 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP