Efficacy of the Wavefront Optimized (WFO) Profile in Non-anterior Astigmatisms
|ClinicalTrials.gov Identifier: NCT01432834|
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : January 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Astigmatism||Other: Laser in situ keratomileusis (LASIK) Other: Photorefractive keratectomy (PRK)||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Efficacy of the Allegretto Wave and the Wavefront Optimized Ablation Profile in Non-anterior Astigmatisms|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||April 2011|
LASIK group (LG group)
Volunteers of this group received LASIK treatment.
Other: Laser in situ keratomileusis (LASIK)
During LASIK treatments the Carriazo-Pendular microkeratome (SCHWIND eye-tech-solutions GmbH & Co.KG, Kleinostheim, Germany) with 130μm cutting head was used for the creation of the flap. The normal value of the negative pressure of the suction ring was between 600-620 mmHg and the velocity of the head movement was constant (3mm/sec). The hinge was created at the 12 o'clock position. The Allegretto Wave excimer laser (software version: 2.020 / WaveLight AG, Erlangen, Germany) was used for all ablations. Attempted ablations were modified according to the "S001 Wellington" nomogram for the "wavefront optimised" protocol.
PRK group (PG group)
Volunteers of this group received PRK treatment
Other: Photorefractive keratectomy (PRK)
The same surgical procedure was applied to all PG participants that included: Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of a sponge saturated with 10% alcohol to the central cornea for 20-30 seconds and subsequent de-epithelialization by means of a hockey knife.The Allegretto Wave excimer laser (software version: 2.020 / WaveLight AG, Erlangen, Germany) was used for all ablations. Attempted ablations were modified according to the "S001 Wellington" nomogram for the "wavefront optimised" protocol. A soft therapeutic lens was applied until complete re-epithelialization of the cornea was detected.
Other Name: Allegretto Wave excimer laser (software version: 2.020 / WaveLight AG, Erlangen, Germany)
- vector analysis of astigmatism correction, following laser in-situ keratomileusis (LASIK) & photorefractive keratectomy (PRK) treatments. [ Time Frame: 6 months postoperatively ]Vector analysis of astigmatism correction was conducted using preoperative and 6-month postoperative data. The following indexes were calculated: a) Correction index (CI) which is determined by the ratio of the surgically induced astigmatism (SIA) to the target induced astigmatism (TIA), b) Difference vector (DV) as an absolute measure of success, and, c) Index of Success (IOS) which is determined by the relationship of the DV to the TIA, as a relative measure of success.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432834
|Eye Institute of Thrace (EIT)|
|Alexandroupolis, Greece, 68100|