An interventional study of Visumax femtosecond laser and Moria M2 microkeratome (MK) in Lasik in Myopia, sponsored by Dar Al Shifa Hospital. Completed. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-06-20.
Sponsored by Dar Al Shifa Hospital · Not applicable, Interventional, and Treatment
this is an interventional prospective clinical study which was conducted to evaluate the efficacy, safety, predictability, ocular aberrations, and flap thickness predictability of Visumax femtosecond laser (FSL) compared to Moria M2 microkeratome (MK) in mild to moderate myopia.
This study included 60 eyes who were divided into two groups. Thirty eyes in group (I) in which the flap was created with Visumax FSL, while in group II (30 eyes) the Moria M2 MK was used. Keratometric, refractive, and aberrometric measurements were compared preoperatively and 3 months postoperatively. The intraoperative subtraction pachymetry (the SP 100 Handy pachymeter (Tomey, Nagoya, Japan) was used for preoperative pachymetry and flap thickness measurement.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's enrollment of 30 is below the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Dar Al Shifa Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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30 eyes were treated by microkeratome
Device: Moria M2 microkeratome (MK)
30 eyes were treated by femtosecond laser
Device: Visumax femtosecond laser
visual outcomes
uncorrected and best corrected distant visual acuity in LogMAR
Time frame: 6 months
refractive outcomes
sphere in diopter, cylinder in diopter cylinder and spherical equivalent in diopter
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
Ran from Jan 2014 to primary completion in May 2014, 4 months.
Of 200 non-industry interventional studies with no phase under Myopia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 4 months is below that.
Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Dar Al Shifa Hospital