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Pupil Centroid Shift Compensation in Photorefractive Keratectomy Candidates

Role of Pupil Centroid Shift Compensation on Lower and Higher Order Aberrations During Photorefractive Keratectomy: An Eye-to-Eye Study

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03844178
Enrollment
104
Registered
2019-02-18
Start date
2019-02-10
Completion date
2019-07-01
Last updated
2019-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pupil Centroid Shift

Brief summary

patients who are candidates of PRK will be recruited in this intrasubject randomized clinical trial. Inclusion criteria are myopia or myopic astigmatism with refractive cylinder. Exclusion criteria were unstable refractive error, age less than 21 years old, corneal opacity, keratoconus, keratoconus suspects, residual corneal stromal thickness less than 350 µm, moderate or severe dry eye disease and any other ocular pathology other than refractive error. Complete eye exam will be performed preoperatively including: uncorrected distance visual acuity (UDVA), best spectacle corrected distance visual acuity (CDVA), cyclorefraction, slit lamp biomicroscopy, Goldmann applannation tonometry, dual scheimpflug tomography (Ziemmer), topography in mesopic condition accompanied by pupilometry and iris registration (Topolyzer Vario, Alcon Laboratories, Inc., Fort Worth, TX), and funduscopy with dilated pupil. Surgical Technique The same surgeon (A.F.) will perform all surgeries. After installation of Tetracaine 1%, periorbital skin will be prepared with povidone iodine 5%. Iris registration will be performed in all eyes before epithelial removal. Ethylalcohol 20.0% into a 9.0 mm well for 20 seconds will be applied on the central cornea, and then the epithelium of the central 9.0 mm area will be removed by hockey knife. In the right eye of each patient PCS compensation will be turned on (PCS-On group) and in the left eye it will be turned off (PCS-Off group). Excimer laser ablation will be performed by Wavelight Allegretto EX500 (Alcon, Fort Worth, TX, USA). Selection of which eye to be first ablated will be done randomly. Randomization will be performed based on a computer software by a Biostatistician which produced the first eye to be operated. Static cyclotorsion compensation will be active in all eyes. The ablation profile will be wavefront-optimized in all cases. Postoperative Course Postoperatively, chloramphenicol 0.5% eye drops and betamethasone 0.1% eye drops will be prescribed every 6 hours for 10 days. Thereafter, Fluorometholone 0.1% eye drops every 6 hours for 1 month and every 8 hours for the next month will be given. Follow-up examinations were scheduled at 1, 2, 3, 4, 7 and 15 days and 1, 2, 3, and 6 months postoperatively. After contact lens removal each follow-up examination includes the UDVA, manifest refraction, and IOP measurements as well as a slit lamp biomicroscopy. Corneal imaging with Galilei tomography, CDVA and cyclorefraction will be performed at the final follow-up examination 6 months postoperatively.

Interventions

PROCEDUREThe option for compensation of Pupil centroid shift was ON

The option for compensation of Pupil centroid shift was ON

PROCEDUREThe option for compensation of Pupil centroid shift was OFF

The option for compensation of Pupil centroid shift was OFF

DRUGinstallation of Tetracaine 1%

installation of Tetracaine 1%

periorbital skin will be prepared with povidone iodine 5%. Iris registration will be performed in all eyes before epithelial removal. Ethylalcohol 20.0% into a 9.0 mm well for 20 seconds will be applied on the central cornea, and then the epithelium of the central 9.0 mm area will be removed by hockey knife. Excimer laser ablation will be performed by Wavelight Allegretto EX500 (Alcon, Fort Worth, TX, USA)

Sponsors

Shahid Beheshti University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* myopia * myopic astigmatism

Exclusion criteria

* unstable refractive error, age less than 21 years old * corneal opacity * keratoconus, keratoconus suspects * residual corneal stromal thickness less than 350 µm * moderate or severe dry eye disease * any other ocular pathology other than refractive error

Design outcomes

Primary

MeasureTime frameDescription
Postoperative refractive error2 monthsSnellen chart and subjective refraction

Secondary

MeasureTime frameDescription
Root Mean Square (RMS) of higher order aberration6 monthswavefront analysis by galilei scan

Countries

Iran

Contacts

Primary ContactAmir Faramarzi, MD
labbafi@hotmail.com009822591616

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026