Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384501
Status:
TERMINATED
Last Update Posted:
2006-10-06
First Post:
2006-10-05
Brief Title:
Management of Patients With Keratoconus With Intacs
Sponsor:
University Hospital of Crete
Organization:
University Hospital of Crete
Study Overview
Official Title:
Intacs for the Treatment of Keratoconus
Status:
TERMINATED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose To evaluate long-term follow up of Intacs microthin prescription inserts Addition Technology Inc Fremont Calif for the management of keratoconus
Design A long-term five years retrospective follow-up study
Design A long-term five years retrospective follow-up study
Detailed Description:
Subjects and Methods
Ethical committee approval was obtained for the original trial and patients were asked to sign an informed consent form in accordance with Institutional guidelines and to the Declaration of Helsinki before treatment and for further follow-up examinations The registration information for this clinical trial is available to the public through the National Institute of Health database
The surgical procedure was done under topical anesthesia Two Intacs segments of 045-mm thickness were inserted so as to embrace the steepest keratoconus meridian according to the topographic image aiming at maximal flattening
The corneal thickness was measured intraoperatively at the incision site and peripherally in the cornea along the ring placement markings with ultrasonic pachymetry Sonogage Cleveland Ohio USA Using a diamond knife set at 70 of the thinnest corneal measurement a 09-mm radial incision was formed and corneal pockets were created using two Sinskey hooks and a Suarez spreader Two corneal tunnels were then formed using clockwise and counterclockwise dissectors under suction created by a vacuum-centering guide The two polymethyl methacrylate PMMA segments 045-mm thickness were implanted in the respective corneal tunnels maintaining a space of approximately 20-mm between their ends and 15 mm between the opposite edge of each segment and the edge of the incision The incision site was sutured using a single 100 nylon stitch
Postoperative evaluation Postoperatively all eyes received antibioticsteroid combination eye drops 4 times per day for 2 weeks In addition all patients were instructed to use preservative-free artificial tears frequently The sutures were removed 2 weeks after surgery
Group differences for continuous variables were tested using the paired Student t tests The change in manifest refraction spherical equivalent MRSE and topographic k values and topographic astigmatism were plotted over time to determine long-term stability and the difference as a function of time was analyzed using paired 2-tailed t tests at time intervals of preoperative to 1 month 1 to 3 months 3 to 6 months 6 to 12 months and every year of follow up period Results are presented as means standard deviation SD A P value less than 05 was regarded as statistically significant
Ethical committee approval was obtained for the original trial and patients were asked to sign an informed consent form in accordance with Institutional guidelines and to the Declaration of Helsinki before treatment and for further follow-up examinations The registration information for this clinical trial is available to the public through the National Institute of Health database
The surgical procedure was done under topical anesthesia Two Intacs segments of 045-mm thickness were inserted so as to embrace the steepest keratoconus meridian according to the topographic image aiming at maximal flattening
The corneal thickness was measured intraoperatively at the incision site and peripherally in the cornea along the ring placement markings with ultrasonic pachymetry Sonogage Cleveland Ohio USA Using a diamond knife set at 70 of the thinnest corneal measurement a 09-mm radial incision was formed and corneal pockets were created using two Sinskey hooks and a Suarez spreader Two corneal tunnels were then formed using clockwise and counterclockwise dissectors under suction created by a vacuum-centering guide The two polymethyl methacrylate PMMA segments 045-mm thickness were implanted in the respective corneal tunnels maintaining a space of approximately 20-mm between their ends and 15 mm between the opposite edge of each segment and the edge of the incision The incision site was sutured using a single 100 nylon stitch
Postoperative evaluation Postoperatively all eyes received antibioticsteroid combination eye drops 4 times per day for 2 weeks In addition all patients were instructed to use preservative-free artificial tears frequently The sutures were removed 2 weeks after surgery
Group differences for continuous variables were tested using the paired Student t tests The change in manifest refraction spherical equivalent MRSE and topographic k values and topographic astigmatism were plotted over time to determine long-term stability and the difference as a function of time was analyzed using paired 2-tailed t tests at time intervals of preoperative to 1 month 1 to 3 months 3 to 6 months 6 to 12 months and every year of follow up period Results are presented as means standard deviation SD A P value less than 05 was regarded as statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None