AstigmatismPhase 3NCT00000123
The Berkeley Orthokeratology Study
A Phase 3 study testing Polymethyl Methacrylate-Silicone Contact Lenses and Polymethyl Methacrylate Contact Lenses in people with Astigmatism and Myopia, run by National Eye Institute (NEI).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Astigmatism, Myopia
- What is being tested?
- Polymethyl Methacrylate-Silicone Contact Lenses and Polymethyl Methacrylate Contact Lenses
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1978to Feb 1979
- Phase
- Phase 3
- 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 20 to 35 years
- All sexes
- Adult
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.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Astigmatism, Myopia
- Being tested
- Polymethyl Methacrylate-Silicone Contact Lenses, Polymethyl Methacrylate Contact Lenses
- Medical subject headings
- Astigmatism, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymethyl Methacrylate-Silicone Contact LensesDevice
Polymethyl Methacrylate Contact LensesDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 1999 (estimated)
- Study startJan 1978
- Study completionFeb 1979
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000123
- Sponsor's protocol ID
- NEI-22
- Status last verified
- Sep 2009
- First submitted
- 23 Sep 1999
- Last updated
- 17 Sep 2009
- Results posted
- No
Publications
Polse KA, Brand RJ. Contact lens effects on ametropia: a current example of the clinical trial. Am J Optom Physiol Opt. 1981 Apr;58(4):281-8.
PubMed 7282852Brand RJ, Polse KA, Schwalbe JS. The Berkeley Orthokeratology Study, Part I: General conduct of the study. Am J Optom Physiol Opt. 1983 Mar;60(3):175-86. doi: 10.1097/00006324-198303000-00005.
PubMed 6342407Polse KA, Brand RJ, Keener RJ, Schwalbe JS, Vastine DW. The Berkeley Orthokeratology Study, part III: safety. Am J Optom Physiol Opt. 1983 Apr;60(4):321-8. doi: 10.1097/00006324-198304000-00011.
PubMed 6344645Polse KA, Brand RJ, Schwalbe JS, Vastine DW, Keener RJ. The Berkeley Orthokeratology Study, Part II: Efficacy and duration. Am J Optom Physiol Opt. 1983 Mar;60(3):187-98. doi: 10.1097/00006324-198303000-00006.
PubMed 6342408Polse KA, Brand RJ, Vastine DW, Schwalbe JS. Corneal change accompanying orthokeratology. Plastic or elastic? Results of a randomized controlled clinical trial. Arch Ophthalmol. 1983 Dec;101(12):1873-8. doi: 10.1001/archopht.1983.01040020875008.
PubMed 6360111Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
PubMed 36809645
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Berkeley Orthokeratology Study
- ClinicalTrials.gov ID
- NCT00000123
- Acronym / sponsor ID
- NEI-22
- Conditions
- Astigmatism, Myopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Jan 1978
- Study completion
- Feb 1979 (actual)
- First posted
- 24 Sep 1999 (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.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Age groups
- Adult
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 |
|---|---|---|
| Polymethyl Methacrylate-Silicone Contact Lenses | Device | – |
| Polymethyl Methacrylate Contact Lenses | Device | – |
Primary outcome
Not reported in the source record.
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 17 Sep 2009.
- Background: PubMed 7282852Polse KA, Brand RJ. Contact lens effects on ametropia: a current example of the clinical trial. Am J Optom Physiol Opt. 1981 Apr;58(4):281-8.
- Background: PubMed 6342407Brand RJ, Polse KA, Schwalbe JS. The Berkeley Orthokeratology Study, Part I: General conduct of the study. Am J Optom Physiol Opt. 1983 Mar;60(3):175-86. doi: 10.1097/00006324-198303000-00005.
- Background: PubMed 6344645Polse KA, Brand RJ, Keener RJ, Schwalbe JS, Vastine DW. The Berkeley Orthokeratology Study, part III: safety. Am J Optom Physiol Opt. 1983 Apr;60(4):321-8. doi: 10.1097/00006324-198304000-00011.
- Background: PubMed 6342408Polse KA, Brand RJ, Schwalbe JS, Vastine DW, Keener RJ. The Berkeley Orthokeratology Study, Part II: Efficacy and duration. Am J Optom Physiol Opt. 1983 Mar;60(3):187-98. doi: 10.1097/00006324-198303000-00006.
- Background: PubMed 6360111Polse KA, Brand RJ, Vastine DW, Schwalbe JS. Corneal change accompanying orthokeratology. Plastic or elastic? Results of a randomized controlled clinical trial. Arch Ophthalmol. 1983 Dec;101(12):1873-8. doi: 10.1001/archopht.1983.01040020875008.
- Derived from this study: PubMed 36809645Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polymethyl Methacrylate-Silicone Contact Lenses and Polymethyl Methacrylate Contact Lenses in people with Astigmatism and Myopia, run by National Eye Institute (NEI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000123, which also lists 6 linked publications.
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 17 Sep 2009.