Pupil Centroid ShiftPhase 2NCT03844178
Pupil Centroid Shift Compensation in Photorefractive Keratectomy Candidates
A Phase 2 study testing The option for compensation of Pupil centroid shift was ON, The option for compensation of Pupil centroid shift was OFF and installation of Tetracaine 1% in people with Pupil Centroid Shift, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Pupil Centroid Shift
- What is being tested?
- The option for compensation of Pupil centroid shift was ON, The option for compensation of Pupil centroid shift was OFF and installation of Tetracaine 1%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteIran
- Study dates
- 10 Feb 2019to 1 Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- myopia
- myopic astigmatism
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran
Amir Faramarzi, MD, 009822591616, labbafi@hotmail.com
About this study
Official title: Role of Pupil Centroid Shift Compensation on Lower and Higher Order Aberrations During Photorefractive Keratectomy: An Eye-to-Eye Study
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.
- Conditions
- Pupil Centroid Shift
- Being 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%, Photorefractive keratectomy (PRK)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The option for compensation of Pupil centroid shift was ONProcedure or surgery
The option for compensation of Pupil centroid shift was ON
The option for compensation of Pupil centroid shift was OFFProcedure or surgery
The option for compensation of Pupil centroid shift was OFF
installation of Tetracaine 1%Drug
installation of Tetracaine 1%
Photorefractive keratectomy (PRK)Procedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| The right eyes with compensation for Pupil centroid shift | Active comparator | Not described Receives: Procedure: The option for compensation of Pupil centroid shift was ON; Drug: installation of Tetracaine 1%; Procedure: Photorefractive keratectomy (PRK) |
| The left eyes without compensation for Pupil centroid shift | Active comparator | Not described Receives: Procedure: The option for compensation of Pupil centroid shift was OFF; Drug: installation of Tetracaine 1%; Procedure: Photorefractive keratectomy (PRK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative refractive error
Snellen chart and subjective refraction
Measured: 2 months
Secondary outcomes (1)
Root Mean Square (RMS) of higher order aberration
wavefront analysis by galilei scan
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start10 Feb 2019 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pupil Centroid ShiftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844178
- Sponsor's protocol ID
- 97362
- Status last verified
- Feb 2019
- First submitted
- 2 Feb 2019
- Last updated
- 18 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Pupil Centroid Shift Compensation on Lower and Higher Order Aberrations During Photorefractive Keratectomy: An Eye-to-Eye Study
- ClinicalTrials.gov ID
- NCT03844178
- Acronym / sponsor ID
- 97362
- Conditions
- Pupil Centroid Shift
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 10 Feb 2019 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The right eyes with compensation for Pupil centroid shift | Active comparator | Procedure: The option for compensation of Pupil centroid shift was ON, Drug: installation of Tetracaine 1%, Procedure: Photorefractive keratectomy (PRK) |
| The left eyes without compensation for Pupil centroid shift | Active comparator | Procedure: The option for compensation of Pupil centroid shift was OFF, Drug: installation of Tetracaine 1%, Procedure: Photorefractive keratectomy (PRK) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- myopia
- myopic astigmatism
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The option for compensation of Pupil centroid shift was ONThe option for compensation of Pupil centroid shift was ON | Procedure or surgery | The right eyes with compensation for Pupil centroid shift |
| The option for compensation of Pupil centroid shift was OFFThe option for compensation of Pupil centroid shift was OFF | Procedure or surgery | The left eyes without compensation for Pupil centroid shift |
| installation of Tetracaine 1%installation of Tetracaine 1% | Drug | The left eyes without compensation for Pupil centroid shift, The right eyes with compensation for Pupil centroid shift |
| Photorefractive keratectomy (PRK)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) | Procedure or surgery | The left eyes without compensation for Pupil centroid shift, The right eyes with compensation for Pupil centroid shift |
Primary outcome
Postoperative refractive error
Time frame: 2 months
Snellen chart and subjective refraction
1 secondary outcome
Root Mean Square (RMS) of higher order aberration
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The option for compensation of Pupil centroid shift was ON, The option for compensation of Pupil centroid shift was OFF and installation of Tetracaine 1% in people with Pupil Centroid Shift, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Faramarzi, MD (009822591616, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative refractive error (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.