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OpenTrials
Completed

NCT Number: NCT03597906

Topography Guided LASIK by Different Protocols for Treatment of Astigmatism

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy

Cairo, 11562, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

topography guided ablation

Procedure

using the data obtained from the topolyzer for correction of refractive errors specially astigmatism we use 3 different treatment protocols

manifest refraction

Procedure

using for ablation the exact manifest refraction

full topography modified refraction

Procedure

full topography modified refraction means changing both sphere and cylinder power in the ablation profile

partial topography modified refraction

Procedure

partial topography modified refraction means changing only cylinder power and axis in the ablation profile

Primary outcomes

  1. post operative residual astigmatism

    Time frame: 3 months

    measuring the post operative residual astigmatism and comparison between the 3 group to reach to the most accurate protocol.

Secondary outcomes

  1. measurement of the postoperative unaided visual acuity

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 24, 2018
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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