Efficacy of the Wavefront Optimized (WFO) Profile in Non-anterior Astigmatisms
Primary Purpose
Astigmatism
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Laser in situ keratomileusis (LASIK)
Photorefractive keratectomy (PRK)
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism focused on measuring non-anterior astigmatism correction, Allegretto Wave excimer laser, wavefront optimized ablation profile (WFO), LASIK, PRK
Eligibility Criteria
Inclusion Criteria:
- astigmatism fault
Exclusion Criteria:
- previous incisional eye surgery
- evidence of any type of corneal pathology
- evidence of any type of optic neuropathy
- history of optic neuropathy
- diabetes mellitus
Sites / Locations
- Eye Institute of Thrace (EIT)
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
LASIK group (LG group)
PRK group (PG group)
Arm Description
Volunteers of this group received LASIK treatment.
Volunteers of this group received PRK treatment
Outcomes
Primary Outcome Measures
vector analysis of astigmatism correction, following laser in-situ keratomileusis (LASIK) & photorefractive keratectomy (PRK) treatments.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01432834
First Posted
September 12, 2011
Last Updated
January 14, 2017
Sponsor
Democritus University of Thrace
1. Study Identification
Unique Protocol Identification Number
NCT01432834
Brief Title
Efficacy of the Wavefront Optimized (WFO) Profile in Non-anterior Astigmatisms
Official Title
Evaluation of the Efficacy of the Allegretto Wave and the Wavefront Optimized Ablation Profile in Non-anterior Astigmatisms
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Democritus University of Thrace
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
Keywords
non-anterior astigmatism correction, Allegretto Wave excimer laser, wavefront optimized ablation profile (WFO), LASIK, PRK
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LASIK group (LG group)
Arm Type
Other
Arm Description
Volunteers of this group received LASIK treatment.
Arm Title
PRK group (PG group)
Arm Type
Other
Arm Description
Volunteers of this group received PRK treatment
Intervention Type
Other
Intervention Name(s)
Laser in situ keratomileusis (LASIK)
Other Intervention Name(s)
Allegretto Wave excimer laser (software version: 2.020 / WaveLight AG, Erlangen, Germany), Carriazo-Pendular microkeratome (SCHWIND eye-tech-solutions GmbH & Co.KG, Kleinostheim, Germany)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Photorefractive keratectomy (PRK)
Other Intervention Name(s)
Allegretto Wave excimer laser (software version: 2.020 / WaveLight AG, Erlangen, Germany)
Intervention Description
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.
Primary Outcome Measure Information:
Title
vector analysis of astigmatism correction, following laser in-situ keratomileusis (LASIK) & photorefractive keratectomy (PRK) treatments.
Description
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.
Time Frame
6 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
astigmatism fault
Exclusion Criteria:
previous incisional eye surgery
evidence of any type of corneal pathology
evidence of any type of optic neuropathy
history of optic neuropathy
diabetes mellitus
Facility Information:
Facility Name
Eye Institute of Thrace (EIT)
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
22690672
Citation
Labiris G, Gatzioufas Z, Giarmoukakis A, Sideroudi H, Kozobolis V. Evaluation of the efficacy of the Allegretto Wave and the Wavefront-optimized ablation profile in non-anterior astigmatisms. Acta Ophthalmol. 2012 Sep;90(6):e442-6. doi: 10.1111/j.1755-3768.2012.02463.x. Epub 2012 Jun 13.
Results Reference
result
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Efficacy of the Wavefront Optimized (WFO) Profile in Non-anterior Astigmatisms
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