Efficacy of the Wavefront Optimized (WFO) Profile in Non-anterior Astigmatisms
Evaluation of the Efficacy of the Allegretto Wave and the Wavefront Optimized Ablation Profile in Non-anterior Astigmatisms
1 other identifier
interventional
74
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 12, 2011
CompletedFirst Posted
Study publicly available on registry
September 13, 2011
CompletedJanuary 18, 2017
January 1, 2017
8 months
September 12, 2011
January 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months postoperatively
Study Arms (2)
LASIK group (LG group)
OTHERVolunteers of this group received LASIK treatment.
PRK group (PG group)
OTHERVolunteers of this group received PRK treatment
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- astigmatism fault
You may not qualify if:
- previous incisional eye surgery
- evidence of any type of corneal pathology
- evidence of any type of optic neuropathy
- history of optic neuropathy
- diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eye Institute of Thrace (EIT)
Alexandroupoli, 68100, Greece
Related Publications (1)
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.
PMID: 22690672RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer of Ophthalmology
Study Record Dates
First Submitted
September 12, 2011
First Posted
September 13, 2011
Study Start
April 1, 2010
Primary Completion
December 1, 2010
Study Completion
April 1, 2011
Last Updated
January 18, 2017
Record last verified: 2017-01