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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P010062 / PAS001 |
| Date Original Protocol Accepted |
06/07/2007
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| Date Current Protocol Accepted |
06/07/2007
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| Study Name |
Long term
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| Device Name |
EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective cohort study conducted in two phases: the Treatment Phase and the Regression Phase. During the Treatment Phase each subject was seen for a Diagnostic Fit Visit, at which time eligibility was assessed, informed consent obtained, and eligible subjects were enrolled into the study. Enrolled subjects were assessed for study lenses and the lenses were ordered. The subjects were scheduled for a Lens Dispensing Visit and a 24-Hour Lens Evaluation Visit. The subjects wore their study lenses on an overnight wear basis. Subjects returned for the 24-Hour Lens Evaluation Visit, and data was evaluated to determine if the subject was a viable candidate to continue the Treatment Phase. If the subject was eligible, the Investigator scheduled follow-up visits. Daily disposable lenses (Bausch and Lomb SofLens one day disposable lenses, known as "maintenance lenses") were dispensed to provide supplemental visual correction during the day as needed for the Ortho-K lens adaptation period. The Regression Phase began after the 3-Month or Exit Visit. Subjects returned for follow-up visits either 5 hours after lens removal on the same day as the 3-Month Visit, or the next day after wearing the Ortho-K lenses the previous night (5 hours after lens removal). They then returned for a 24-Hour Visit, a 3-Day Visit, and a 1-Week Visit. If the subject was discontinued prior to the 3-Month Visit after wearing Ortho-K lenses, he/she was also followed through the same Regression Phase schedule.
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| Study Population |
The lenses are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear for the temporaly reduction of myopia up to 5.00 diopters with eyes having astigmatism up to 1 .50 diopters. The lenses may only be disinfected using a chemnical disinfection system. The study population is as per device indication.
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| Sample Size |
150 subjects (both eyes), 9 sites
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| Key Study Endpoints |
The primary endpoints were measured during the Regression Phase of the study, as follows: - The proportion of eyes that achieve manifest refractive spherical equivalent (MRSE) within +/- 0.50 and +/- 1.00 diopter (D) of pretreatment, - The proportion of eyes that achieve keratometry within 0.50 and +/- 1.00 D of pretreatment, - The proportion of eyes with best spectacle corrected; (BSCVA) within 1 line and 2 lines of pretreatment, - The time required to achieve 20/40 or worse uncorrected visual acuity (VA) and the time required to achieve -1.00D or worse MRSE
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| Follow-up Visits and Length of Follow-up |
1. One week ± 3 days, AM VISIT WITHIN 2 HRS OF LENS REMOVAL
2. One month ± 1 week, AM VISIT WITHIN 2 HRS OF LENS REMOVAL
If refraction is stable in both eyes, make an appointment for cessation of treatment, i.e., removal of lenses. This appointment should be not more than 7 days from the date of' this visit. Patients should continue to wear lenses overnight, removing them during the daytime hours and should not remove lenses the morning of the next scheduled office visit. Lens removal shall be in-office. Or, if not stable
2. Two months ± 2 weeks, AM VISIT WITHLN 2 HRS OF LENS REMOVAL
If refraction is stable in both eyes, make an appointment for cessation of treatment, i.e. removal of lenses. This appointment should be not more than 7 days from the date of this visit. Patients should continue to wear lenses overnight, removing them during the daytime hours and should not remove lenses the morning of the next scheduled office visit. Lens removal shall be in-office. Or if not stable
3. Three months ± 2 weeks;. AM V ISIT WITHIN 2 HRS OF LENS REMOVAL
If reaction is stable in both eyes, make an appointment for cessation of treatment, i.e., removal of lenses. This appointment should be not more than 7 days from the date of this visit, Patients
should continue to wear lenses overnight, removing them during the daytime hours and should not remove lenses the morning of the next scheduled office visit. Lens removal shall be in-office.
Or, if not stable
Discontinue from Regression Study if both eyes are not stable at 3 months.
4. Post cessation of treatment
A. Zero Time-Office visit for- initial lens removal. Should be am visit (8&9am).
B. Noon - Same date as lens removal (3-4 hrs post lens removal).
C. After Hours - Same dale as lens removal (8-10 hrs post lens removal).
D. Day 1 - Next day after lens removal (22-32 hrs post lens removal).
E. Day 2 - (45-57 hrs post/lens removal).
F. Day 3 - (68-82 hrs post lens removal).
G. 1 Week - (6-9 days post lens removal).
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
138
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| Actual Number of Sites Enrolled |
9
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| Patient Follow-up Rate |
70%
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| Final Safety Findings |
There were no adverse events related to the study product. Three eyes reported to have a grade 3 slit lamp finding during the Treatment Phase (2 eyes completed, 1 eye discontinued) and no reports of a grade 4 slit lamp finding during the Treatment Phase
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| Final Effect Findings |
At the initial diagnostic visit, none (0%) of the eyes achieving stability had uncorrected visual acuity (UCVA) of 20/20 or better and only 12 eyes (6.5%) had UCVA of 20/40 or better. By the end of the Treatment Phase, 3-Month Visit, most eyes that achieved stability had an MRSE that was between -1.00D and +1.00D (177 eyes/ 96.2%). The refractive change from pretreatment resulted in excellent uncorrected distance visual acuity where 144 eyes (78.2%) had UCVA of 20/20 or better and 184 eyes (100%) had UCVA of 20/40 or better. Following lens removal, the stability of the vision was good during the day. At the 5-Hour Visit in the Regression Phase, there were 141 eyes (76.6%) that had UCVA of 20/20 or better and 182 eyes (98.9%) with 20/40 or better. While the MRSE regressed toward the pretreatment MRSE as the Regression Phase continued, there were still 121eyes (66.5%) with UCVA of 20/40 or better at the 24-Hour visit and 52 eyes (28.6%) were 20/20 or better.
Although the there was no study requirement for eyes that achieved stability to be followed until complete return to pretreatment status, 128 of 184 eyes (69.6%) had regressed within ± 0.50D of pretreatment MRSE and 172 of 184 eyes (93.5%) had regressed within ± 1.00D of pretreatment MRSE by the 1-Week Regression Phase Visit. The BSCVA comparison of pretreatment to the final Regression Phase demonstrated that 177 eyes (97.8%) had no change (96.7%) or improved a line (1.1%) from the pretreatment BSCVA. The results demonstrated that subject¿s eyes were able to return to pretreatment values.
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| Study Strengths & Weaknesses |
A strength of this study was the large sample size, which was enough to properly evaluate the safety of this device. However, lack of a control group limits interpretation of study results because findings could be due to factors related or unrelated to the device. The follow up rate was only 70%, increasing the likelihood for biased results as usually subjects that remain on the study may differ from those that are lost to follow-up.
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| Recommendations for Labeling Changes |
It is recommended that the label be updated to reflect the long-term results. The post-approval study design, methods, safety and effectiveness results should be included in the labeling from both phases (i.e., treatment and regression phases).
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