Refractive Errors Clinical Trial
Official title:
Comparison of Corneal Flap Thickness Using Visumax Femto-Lasik With SubBowman Keratomileusis (SBK) Microkeratome
Verified date | July 2021 |
Source | Al-Kindy College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Laser Insitu keratomileusis (LASIK) has become the most popular procedure for refractive error correction. Lasik flap creation is the first and critical step during LASIK surgery because of its consensual effect on a residual stromal bed, corneal biomechanics, and hence the future risk of ectasia⁴.In the current study, we compared the Visumax FSL flap thickness predictability, accuracy, and variability with the flap created by single-use Moria SBK microkeratome.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 30, 2021 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 38 Years |
Eligibility | Inclusion Criteria: - Having refractive errors range from -2 to- 6 DS and from -1 to -3.00DC. - They have stable refraction for at least one year prior to surgery. - Normal topography by Placido-Scheimpflug (Sirius, Costruzione Strumenti Oftalmici, Florence, Italia) and normal corneal epithelial map by Anterior segment-OCT system (Optovue Inc, Fremont, California, USA) Exclusion Criteria: 1. Patient with suspicious topography and or corneal epithelial map. 2. Patient with corneal pachymetry below 500µm. 3. Patients who have a history of previous ocular surgery or trauma. 4. Patient with a current or previous history of herpes simplex or herpes zoster. 5. Patient with severe dry eye, diabetes, thyrotoxicosis, and connective tissue diseases. 6. Patient with Combined ocular diseases like retinal dystrophy or glaucoma. 7. Patient with a history of contact lenses use was meant to stop the use of soft contact lenses for at least 2 weeks or hard type for at least 4 weeks before topography and other investigations were done. 8. Patient who refrains from the required follow-up visits; have been excluded from the study. - |
Country | Name | City | State |
---|---|---|---|
Iraq | Eye Speciality private hospital | Baghdad |
Lead Sponsor | Collaborator |
---|---|
Suzan A Rattan |
Iraq,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Right eye corneal flap thickness was measured by optical coherence tomography(OCT). | The lasik flap thickness in the right eye in both groups were measured six months after the procedures using non touch method by anterior segment OCT without instillation of topical anaesthesia, at seven points in each eye (one central and 3 points at each sides of horizontal meridian).The three nasal points were located (1mm, 2mm, 3mm respectively) from the center and remaining three temporal points located again ( 1mm, 2mm, 3mm) from the center. Data from both groups were comparing to evaluate predictability and variability of the flap thickness. | 6-months postoperatively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04532099 -
Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses
|
N/A | |
Completed |
NCT05039112 -
Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses
|
N/A | |
Completed |
NCT03670303 -
Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan
|
N/A | |
Completed |
NCT02255474 -
Bifocal Lenses In Nearsighted Kids
|
N/A | |
Not yet recruiting |
NCT03222661 -
Direct Comparison of SVOne Obtained Refraction to Subjective Manifest Refraction
|
N/A | |
Completed |
NCT04055519 -
Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
|
N/A | |
Recruiting |
NCT05049070 -
Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction
|
N/A | |
Completed |
NCT04527978 -
Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1
|
N/A | |
Completed |
NCT01430247 -
Vision Screening for the Detection of Amblyopia
|
N/A | |
Recruiting |
NCT06077682 -
Cycloplegic Refraction in Pediatric Patients With Esotropia
|
Phase 4 | |
Not yet recruiting |
NCT04077086 -
Correcting Myopia Among Secondary School Children to Increase Academic High School Attendance Rates in Rural Communities
|
N/A | |
Completed |
NCT04528017 -
Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 2
|
N/A | |
Withdrawn |
NCT04352868 -
Customizing Myopia Control With Multifocal Toric Contact Lens
|
N/A | |
Recruiting |
NCT04338880 -
Academic Performance and Refractive Error
|
||
Recruiting |
NCT04545073 -
Outcomes of a Trifocal IOL in Post-refractive Patients
|
||
Enrolling by invitation |
NCT05992675 -
Air Optix® Night and Day® Aqua Continuous Wear
|
||
Enrolling by invitation |
NCT05976750 -
Air Optix® Night and Day® Aqua Daily Wear
|
||
Recruiting |
NCT04693247 -
Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction
|
N/A | |
Recruiting |
NCT06065631 -
Seeing to Learn in Sierra Leone
|
N/A | |
Not yet recruiting |
NCT05550740 -
Repeated Low-Level Red-Light Therapy for Shortening Axial Length
|
N/A |