Topography Guided LASIK by Different Protocols for Treatment of Astigmatism

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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Surgery
• Intervention / Treatment: Procedure: topography guided ablation; Procedure: manifest refraction; Procedure: partial topography modified refraction; Procedure: full topography modified refraction

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Kasr Alainy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Mohmed Hosny, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): January 20, 2020

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: July 22, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 26, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Astigmatism; LASIK; Topography guided ablation
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: N-18-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No