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Topography Guided LASIK by Different Protocols for Treatment of Astigmatism

Primary Purpose

Refractive Surgery

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
topography guided ablation
manifest refraction
full topography modified refraction
partial topography modified refraction
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Surgery focused on measuring Topography guided ablation, Astigmatism, LASIK

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kasr Alainy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A: Manifest

Group B: partial TMR

Group C: Full TMR

Arm Description

20 eyes will be treated using Contoura, topography guided ablation vision with the standard manifest refraction.

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).

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).

Outcomes

Primary Outcome Measures

post operative residual astigmatism
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
measurement of the postoperative unaided visual acuity and comparison between the 3 group to reach to the most accurate protocol.

Full Information

First Posted
June 21, 2018
Last Updated
January 26, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03597906
Brief Title
Topography Guided LASIK by Different Protocols for Treatment of Astigmatism
Official Title
Comparison of the Outcome of Topography Modified Refraction Correction to Standard Clinical Refraction Correction in Myopic Astigmatic Topography-guided LASIK
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Surgery
Keywords
Topography guided ablation, Astigmatism, LASIK

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, randomized and comparative interventional study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Manifest
Arm Type
Experimental
Arm Description
20 eyes will be treated using Contoura, topography guided ablation vision with the standard manifest refraction.
Arm Title
Group B: partial TMR
Arm Type
Experimental
Arm Description
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).
Arm Title
Group C: Full TMR
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
topography guided ablation
Intervention Description
using the data obtained from the topolyzer for correction of refractive errors specially astigmatism we use 3 different treatment protocols
Intervention Type
Procedure
Intervention Name(s)
manifest refraction
Intervention Description
using for ablation the exact manifest refraction
Intervention Type
Procedure
Intervention Name(s)
full topography modified refraction
Intervention Description
full topography modified refraction means changing both sphere and cylinder power in the ablation profile
Intervention Type
Procedure
Intervention Name(s)
partial topography modified refraction
Intervention Description
partial topography modified refraction means changing only cylinder power and axis in the ablation profile
Primary Outcome Measure Information:
Title
post operative residual astigmatism
Description
measuring the post operative residual astigmatism and comparison between the 3 group to reach to the most accurate protocol.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
measurement of the postoperative unaided visual acuity
Description
measurement of the postoperative unaided visual acuity and comparison between the 3 group to reach to the most accurate protocol.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Estimated postoperative residual stromal bed thickness of less than 300µm. Glaucomatous patients. Patients with keratoconus. Patients with pervious refractive surgery. History of previous ocular trauma or surgery. History of recent herpetic ulcer or viral keratitis. Basement membrane disease, history of recurrent corneal erosions. Sicca syndrome, dry eye.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohmed Hosny, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Kasr Alainy
City
Cairo
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

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Topography Guided LASIK by Different Protocols for Treatment of Astigmatism

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