NCT03597906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

June 21, 2018

Last Update Submit

January 26, 2020

Conditions

Refractive Surgery

Keywords

Topography guided ablationAstigmatismLASIK

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • measurement of the postoperative unaided visual acuity

    3 months

Study Arms (3)

Group A: Manifest

EXPERIMENTAL

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

Procedure: topography guided ablationProcedure: manifest refraction

Group B: partial TMR

EXPERIMENTAL

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 ablationProcedure: partial topography modified refraction

Group C: Full TMR

EXPERIMENTAL

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 ablationProcedure: full topography modified refraction

Interventions

topography guided ablationPROCEDURE

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

Group A: ManifestGroup B: partial TMRGroup C: Full TMR
manifest refractionPROCEDURE

using for ablation the exact manifest refraction

Group A: Manifest
full topography modified refractionPROCEDURE

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

Group C: Full TMR
partial topography modified refractionPROCEDURE

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

Group B: partial TMR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Mohmed Hosny, MD

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, randomized and comparative interventional study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the principal investigator

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 24, 2018

Study Start

August 15, 2018

Primary Completion

November 15, 2019

Study Completion

January 20, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

EG(1)