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Topography-Guided Customized PRK Versus Q-value Adjusted PRK in Correction of Myopia With or Without Astigmatism

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PRK
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age more than 18 years
  • Myopia with up to -6.5 D with or without astigmatism up to -4.75 D

Exclusion Criteria:

  • anterior segment abnormalities (ie, cataracts, corneal scarring)
  • basement membrane disease
  • history of recurrent corneal erosions
  • Schirmer's test less than 5 mm
  • established or forme fruste keratoconus
  • macular or retinal disease
  • current use of immunosuppressive therapy
  • autoimmune disease
  • pregnancy, and lactation

Sites / Locations

  • Eyecare centre
  • Dar Al Oyun hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

topography guided PRK in one eye

Q-value adjusted ( custom Q) PRK in the other eye

Arm Description

Topography-guided (placido disk- based) using T-CAT Contoura treatment.

The target Q will be estimated according to a nomogram considering the patient's age

Outcomes

Primary Outcome Measures

change in Postoperative spherical equivalent depending on manifest refraction after autorefractometer
change in visual acuity using snellen chart
change in corneal wavefront aberrations
assessed by topolyzer
change in Q value anterior at 6mm RMS, RMS of astigmatism, RMS of coma and RMS of spherical aberrations. Strehl ratio : Qvalue,RMS,strehl ratio by CSO Sirius scheimpflug
by CSO Sirius scheimpflug
change in total RMS
by CSO Sirius scheimpflug
change in strehl ratio
by CSO scheimpflug
change in Q value
assessed by topolyzer

Secondary Outcome Measures

efficacy:ratio of postoperative decimal UDVA to preoperative decimal CDVA
ratio of postoperative decimal UDVA to preoperative decimal CDVA
contrast sensitivity
cambridge low contrast sensitivity
predictability
eyes within 1.0 D of emmetropia
safety:ratio of mean preoperative decimal CDVA to mean postoperative decimal CDVA
ratio of mean preoperative decimal CDVA to mean postoperative decimal CDVA
stability
change of more than 0.5D over

Full Information

First Posted
August 8, 2017
Last Updated
July 1, 2020
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03291873
Brief Title
Topography-Guided Customized PRK Versus Q-value Adjusted PRK in Correction of Myopia With or Without Astigmatism
Official Title
Topography-Guided Customized PRK (Photorefractive Keratectomy) Versus Q-value Adjusted PRK in Correction of Myopia With or Without Astigmatism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
June 25, 2019 (Actual)
Study Completion Date
June 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study will include patients who will undergo PRK in both eyes, for each patient each eye will be randomly allocated to one of 2 procedures: topography-guided ablation in one eye (group I) and Q-factor customized ablation in the other eye (group II). Alcon/Wavelight Light Laser Technolo¬gie (GmbH, Erlangen, Germany) will be used for photoablation. The wavelight Topolyzer (Wavelight AG, Erlan¬gen, Germany)and CSO Sirius scheimpflug camera combined with Placido corneal topography (CSO, Florence,Italy) will be used before and 1, 3 and 6 months after PRK. Refrac¬tive visual outcomes and corneal aberration changes will be compared between the two treatment modalities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
topography guided PRK in one eye
Arm Type
Active Comparator
Arm Description
Topography-guided (placido disk- based) using T-CAT Contoura treatment.
Arm Title
Q-value adjusted ( custom Q) PRK in the other eye
Arm Type
Active Comparator
Arm Description
The target Q will be estimated according to a nomogram considering the patient's age
Intervention Type
Procedure
Intervention Name(s)
PRK
Intervention Description
PRK using Alcon-Wavelight Excimer Laser EX 500
Primary Outcome Measure Information:
Title
change in Postoperative spherical equivalent depending on manifest refraction after autorefractometer
Time Frame
1 , 3 and 6 months postoperative
Title
change in visual acuity using snellen chart
Time Frame
1 , 3 and 6 months postoperative
Title
change in corneal wavefront aberrations
Description
assessed by topolyzer
Time Frame
1 , 3 and 6 months postoperative
Title
change in Q value anterior at 6mm RMS, RMS of astigmatism, RMS of coma and RMS of spherical aberrations. Strehl ratio : Qvalue,RMS,strehl ratio by CSO Sirius scheimpflug
Description
by CSO Sirius scheimpflug
Time Frame
1,3 and 6months
Title
change in total RMS
Description
by CSO Sirius scheimpflug
Time Frame
1,3 and 6months
Title
change in strehl ratio
Description
by CSO scheimpflug
Time Frame
1,3 and 6 months
Title
change in Q value
Description
assessed by topolyzer
Time Frame
1,3 and 6 months
Secondary Outcome Measure Information:
Title
efficacy:ratio of postoperative decimal UDVA to preoperative decimal CDVA
Description
ratio of postoperative decimal UDVA to preoperative decimal CDVA
Time Frame
6 months
Title
contrast sensitivity
Description
cambridge low contrast sensitivity
Time Frame
6 months
Title
predictability
Description
eyes within 1.0 D of emmetropia
Time Frame
6 months
Title
safety:ratio of mean preoperative decimal CDVA to mean postoperative decimal CDVA
Description
ratio of mean preoperative decimal CDVA to mean postoperative decimal CDVA
Time Frame
6 months
Title
stability
Description
change of more than 0.5D over
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age more than 18 years Myopia with up to -6.5 D with or without astigmatism up to -4.75 D Exclusion Criteria: anterior segment abnormalities (ie, cataracts, corneal scarring) basement membrane disease history of recurrent corneal erosions Schirmer's test less than 5 mm established or forme fruste keratoconus macular or retinal disease current use of immunosuppressive therapy autoimmune disease pregnancy, and lactation
Facility Information:
Facility Name
Eyecare centre
City
Maadi
State/Province
Cairo
Country
Egypt
Facility Name
Dar Al Oyun hospital
City
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Topography-Guided Customized PRK Versus Q-value Adjusted PRK in Correction of Myopia With or Without Astigmatism

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