Topography Guided LASIK by Different Protocols for Treatment of Astigmatism
Study Details
Study Description
Brief Summary
Background and Rationale:
LASIK has been among the highest satisfaction rates of surgical procedures, ranging from 82%-98%. Different ablation profiles have been developed over the years. The purpose of this study is to validate this novel measurement by comparing the visual outcomes when the TMR is used in myopic astigmatic LASIK to using the standard manifest refraction or the Topolyzer measurements alone.
Objectives :
To evaluate the safety, efficacy and predictability of topography-guided myopic LASIK with three different refraction treatment strategies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Candidates for refractive surgery above 18 years with myopic astigmatism and no previous ocular surgery.
Sample size 60 eyes. surgery:
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60 eyes of myopic topography-guided LASIK procedures with the same refractive platform (FS200 femtosecond to create a flap between90: 110 μm with diameter 8:9 mm and EX500 excimer lasers) will be randomized for treatment as follows:
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Group A: 20 eyes will be treated using Contoura vision with the standard manifest refraction.
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Group B: 20 eyes will be treated with Contoura vision using the topographic astigmatic power and axis and without change in the spherical power (using the same spherical power as the manifest refraction).
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Group C [TMR]: 20 eyes will be treated with Contoura vision using the topographic astigmatic power and axis and modifying the spherical power to obtain the same spherical equivalent as the manifest refraction. This is done by subtracting half of the difference between topographic astigmatic power and the manifest astigmatic power from the spherical power (topography-modified treatment refraction).
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The standard postoperative treatment is combined steroids and antibiotics eye drops 5 times daily for one week ,then three times daily for three days and lubricant eye drops 5 times daily for six months.
Postoperatively, the patients will be examined at 1 week, 1 month and 3 months. All postoperative follow-up visits included measurement of UDVA, CDVA (if indicated) and refraction, besides full ophthalmological examination and performing pentacam and topolyzer after 3 months
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A: Manifest 20 eyes will be treated using Contoura, topography guided ablation vision with the standard manifest refraction. |
Procedure: topography guided ablation
using the data obtained from the topolyzer for correction of refractive errors specially astigmatism we use 3 different treatment protocols
Procedure: manifest refraction
using for ablation the exact manifest refraction
|
| Experimental: Group B: partial TMR 20 eyes will be treated with Contoura vision, topography guided ablation using the topographic astigmatic power and axis and without change in the spherical power (using the same spherical power as the manifest refraction). |
Procedure: topography guided ablation
using the data obtained from the topolyzer for correction of refractive errors specially astigmatism we use 3 different treatment protocols
Procedure: partial topography modified refraction
partial topography modified refraction means changing only cylinder power and axis in the ablation profile
|
| Experimental: Group C: Full TMR 20 eyes will be treated with Contoura vision, topography guided ablation using the topographic astigmatic power and axis and modifying the spherical power to obtain the same spherical equivalent as the manifest refraction. This is done by subtracting half of the difference between topographic astigmatic power and the manifest astigmatic power from the spherical power (topography-modified treatment refraction). |
Procedure: topography guided ablation
using the data obtained from the topolyzer for correction of refractive errors specially astigmatism we use 3 different treatment protocols
Procedure: full topography modified refraction
full topography modified refraction means changing both sphere and cylinder power in the ablation profile
|
Outcome Measures
Primary Outcome Measures
- post operative residual astigmatism [3 months]
measuring the post operative residual astigmatism and comparison between the 3 group to reach to the most accurate protocol.
Secondary Outcome Measures
- measurement of the postoperative unaided visual acuity [3 months]
measurement of the postoperative unaided visual acuity and comparison between the 3 group to reach to the most accurate protocol.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Stable refractive error: Myopic astigmatism ≥ -1.5 D
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Valid Topolyzer maps (at least four out of eight right maps with green analyzed area and the registration box is green).
Exclusion Criteria:
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Estimated postoperative residual stromal bed thickness of less than 300µm.
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Glaucomatous patients.
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Patients with keratoconus.
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Patients with pervious refractive surgery.
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History of previous ocular trauma or surgery.
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History of recent herpetic ulcer or viral keratitis.
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Basement membrane disease, history of recurrent corneal erosions.
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Sicca syndrome, dry eye.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kasr Alainy | Cairo | Egypt | 11562 |
Sponsors and Collaborators
- Cairo University
Investigators
- Study Director: Mohmed Hosny, MD, Cairo University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- N-18-2018