Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT01432834
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2011-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of the Wavefront Optimized (WFO) Profile in Non-anterior Astigmatisms
Sponsor:
Democritus University of Thrace
Organization:
Study Overview
Official Title:
Evaluation of the Efficacy of the Allegretto Wave and the Wavefront Optimized Ablation Profile in Non-anterior Astigmatisms
Status:
COMPLETED
Status Verified Date:
2017-01
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:
The purpose of the study was to assess the efficacy of the Allegretto Wave excimer laser and the wavefront optimized ablation profile in correcting primarily non-anterior astigmatism faults, following laser in-situ keratomileusis (LASIK) and photorefractive keratectomy (PRK).
Detailed Description:
Different optical components of the eye contribute to the total astigmatism error.In specific, the anterior corneal surface is responsible for the anterior component of astigmatism fault (anterior astigmatism), while the posterior corneal surface and the lens are responsible for the posterior one (posterior astigmatism).
Regarding our study, 74 refractive surgery candidates were recruited. Only one eye from each candidate was randomly enrolled in the study. Of them, 40 eyes underwent LASIK treatment (LG group), while 34 eyes underwent PRK treatment (PG group). The Allegretto Wave excimer laser (software version: 2.020 / WaveLight AG, Erlangen, Germany) was used for the ablation in all groups. Preoperatively, the ocular residual astigmatism (ORA) was calculated for each eye, according to which each astigmatism fault was characterized as primarily anterior or non-anterior.ORA is the vectorial value of astigmatism arising from non-anterior sources. Its amount on total astigmatism (R) is determined by the magnitude ratio ORA/R. Ratios below 1 indicate primarily anterior astigmatism, while ratios above 1 indicate primarily non-anterior astigmatism. 20 LG eyes and 16 PG eyes presented primarily anterior astigmatism (LG-A and PG-A subgroups, respectively), while 20 LG eyes and 18 PG eyes demonstrated primarily non-anterior astigmatism (LG-NA and PG-NA subgroups, respectively). Postoperatively, vector analysis of astigmatism correction was conducted; The following indexes were calculated: a) Correction index (CI), b) Difference vector (DV) and c) Index of Success (IOS).
Regarding our study, 74 refractive surgery candidates were recruited. Only one eye from each candidate was randomly enrolled in the study. Of them, 40 eyes underwent LASIK treatment (LG group), while 34 eyes underwent PRK treatment (PG group). The Allegretto Wave excimer laser (software version: 2.020 / WaveLight AG, Erlangen, Germany) was used for the ablation in all groups. Preoperatively, the ocular residual astigmatism (ORA) was calculated for each eye, according to which each astigmatism fault was characterized as primarily anterior or non-anterior.ORA is the vectorial value of astigmatism arising from non-anterior sources. Its amount on total astigmatism (R) is determined by the magnitude ratio ORA/R. Ratios below 1 indicate primarily anterior astigmatism, while ratios above 1 indicate primarily non-anterior astigmatism. 20 LG eyes and 16 PG eyes presented primarily anterior astigmatism (LG-A and PG-A subgroups, respectively), while 20 LG eyes and 18 PG eyes demonstrated primarily non-anterior astigmatism (LG-NA and PG-NA subgroups, respectively). Postoperatively, vector analysis of astigmatism correction was conducted; The following indexes were calculated: a) Correction index (CI), b) Difference vector (DV) and c) Index of Success (IOS).
Study Oversight
Has Oversight DMC:
False
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?: