Topography Guided LASIK by Different Protocols for Treatment of Astigmatism

Refractive Surgery Clinical Trial

Official title:

Comparison of the Outcome of Topography Modified Refraction Correction to Standard Clinical Refraction Correction in Myopic Astigmatic Topography-guided LASIK

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597906
• Other study ID #: N-18-2018
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: January 20, 2020

Study information

• Verified date: January 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Candidates for refractive surgery above 18 years with myopic astigmatism and no previous ocular surgery.

Sample size 60 eyes. surgery:

• 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:

• Group A: 20 eyes will be treated using Contoura vision with the standard manifest refraction.

• 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).

• 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).

• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 20, 2020
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stable refractive error: Myopic astigmatism = -1.5 D

• Valid Topolyzer maps (at least four out of eight right maps with green analyzed area and the registration box is green).

Exclusion Criteria:

1. Estimated postoperative residual stromal bed thickness of less than 300µm.

2. Glaucomatous patients.

3. Patients with keratoconus.

4. Patients with pervious refractive surgery.

5. History of previous ocular trauma or surgery.

6. History of recent herpetic ulcer or viral keratitis.

7. Basement membrane disease, history of recurrent corneal erosions.

8. Sicca syndrome, dry eye.

Related Conditions & MeSH terms

• Astigmatism
• Refractive Surgery

Intervention

Procedure:
• topography guided ablation
using the data obtained from the topolyzer for correction of refractive errors specially astigmatism we use 3 different treatment protocols
• manifest refraction
using for ablation the exact manifest refraction
• full topography modified refraction
full topography modified refraction means changing both sphere and cylinder power in the ablation profile
• partial topography modified refraction
partial topography modified refraction means changing only cylinder power and axis in the ablation profile

Locations

Country	Name	City	State
Egypt	Kasr Alainy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post operative residual astigmatism	measuring the post operative residual astigmatism and comparison between the 3 group to reach to the most accurate protocol.	3 months
Secondary	measurement of the postoperative unaided visual acuity	measurement of the postoperative unaided visual acuity and comparison between the 3 group to reach to the most accurate protocol.	3 months