NCT03844178

Pupil Centroid Shift Compensation in Photorefractive Keratectomy Candidates

Status unknown Phase 2 Last updated 18 February 2019

What this trial tests

Phase 2 trial testing The option for compensation of Pupil centroid shift was ON in Pupil Centroid Shift in 104 participants. Status unknown.

Timeline

10 February 2019

Primary endpoint
1 June 2019

1 July 2019

Quick facts

Lead sponsor	Shahid Beheshti University of Medical Sciences
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	104
Start date	10 February 2019
Primary completion	1 June 2019
Estimated completion	1 July 2019
Sites	1 location across Iran

Drugs / interventions tested

• The option for compensation of Pupil centroid shift was ON
• The option for compensation of Pupil centroid shift was OFF
• installation of Tetracaine 1% — full drug profile →
• Photorefractive keratectomy (PRK)

Conditions studied

• Pupil Centroid Shift — all drugs for Pupil Centroid Shift →

Sponsor

Shahid Beheshti University of Medical Sciences

Who can join

Adults 18 to 40, any sex, with Pupil Centroid Shift. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.