KeratoconuskeratoconusNCT03890718
Topography Versus Non-Topography-Guided PRK With CXL in Keratoconus
A study testing Photorefractive keratectomy in mile keratoconus in people with Keratoconus, run by Shahid Beheshti University at 1 site in Iran.
Trial summary
To our knowledge, this study is one of the first to compare the visual results of non-topography-guided and topography-guided photorefractive keratectomy (PRK) applying sequential and simultaneous corneal cross-linking (CXL) treatment for keratoconus. Read more about this study
- Who is it for?
- Ages 34 to 41 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- Photorefractive keratectomy in mile keratoconus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIran
- Study dates
- 30 Mar 2017to 15 Dec 2023
- Phase
- Interventional
- 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 34 to 41 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 34 (range from 34 to 41)
- stable corneal topography and refraction for at least six months
- estimated residual bed thickness of >410 µm
Who cannot join
- presence of macular or retinal disease,
- dry eye
- history of recurrent corneal erosions
- anterior segment abnormalities
- unstable refractive error
- post-surgically residual stromal bed thickness of under 350 mm
Show all 12Show fewer
- autoimmune disease
- collagen vascular disease
- immunosuppressive therapy or current use of systemic corticosteroids
- diabetes mellitus
- pregnancy
- lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topography Versus Non-Topography-Guided Photorefractive Keratectomy With Corneal Cross-Linking Variations in Keratoconus
To our knowledge, this study is one of the first to compare the visual results of non-topography-guided and topography-guided photorefractive keratectomy (PRK) applying sequential and simultaneous corneal cross-linking (CXL) treatment for keratoconus. Considering recent advances in cross-linking and imaging in keratoconus, the outcomes of this study can lead us to several non-invasive algorithm management options.
Read the detailed description
Interventional and comparative prospective study: Sixty-nine eyes (38 patients) suffering from keratoconus (stages 1-2 Amsler-Krumeich classification) were divided into four groups. The four groups underwent topography- and non-topography-guided PRK with sequential and simultaneous CXL. The main outcome measures were pre- and postoperative uncorrected distance visual acuity (UDVA), best corrected distance visual acuity (CDVA), manifest refraction, contrast sensitivity, and keratometry.
- Conditions
- Keratoconus
- Being tested
- Photorefractive keratectomy in mile keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photorefractive keratectomy in mile keratoconusProcedure or surgery
Also called Advance surface abelation in mild keratoconus
Topo-guided photorefractive keratectomy will be performed using an excimer laser (Allegretto Wave Topolyzer, Alcon, Inc.) with a 6 mm optical area and a transition area of 2 mm in all eyes. At that point, the partial topography-guided photorefractive keratectomy laser treatment will be finished. The arrangement will be to treat 70% of the cylindrical and spherical part to not surpass 50μm of stromal expulsion. The estimation of 50μm as the most extreme removal depth recommended by Kanellopoulos in Athens protocol will be chosen
| Study group | Role | What they receive |
|---|---|---|
| Photorefractive keratectomy in mile keratoconus | Experimental | Photorefractive keratectomy in mile keratoconus type of corneal surface ablation in for correct refractive error Receives: Procedure: Photorefractive keratectomy in mile keratoconus |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
Visual acuity (VA) commonly refers to the clarity of vision
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start30 Mar 2017
- Primary completion30 Sep 2022 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, farinaz doroodgar, Shahid Beheshti University
- Investigators
- Jorge Alio, MD,PhD, Study chair, Division of Ophthalmology, Universidad Miguel Hernández, Alicante, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890718
- Sponsor's protocol ID
- ShaheidBU
- Acronym
- keratoconus
- Status last verified
- Jan 2022
- First submitted
- 25 Mar 2019
- Last updated
- 18 Apr 2022
- 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 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topography Versus Non-Topography-Guided Photorefractive Keratectomy With Corneal Cross-Linking Variations in Keratoconus
- ClinicalTrials.gov ID
- NCT03890718
- Acronym / sponsor ID
- keratoconus / ShaheidBU
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 26 Mar 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.
To our knowledge, this study is one of the first to compare the visual results of non-topography-guided and topography-guided photorefractive keratectomy (PRK) applying sequential and simultaneous corneal cross-linking (CXL) treatment for keratoconus. Considering recent advances in cross-linking and imaging in keratoconus, the outcomes of this study can lead us to several non-invasive algorithm management options.
Detailed description
Interventional and comparative prospective study: Sixty-nine eyes (38 patients) suffering from keratoconus (stages 1-2 Amsler-Krumeich classification) were divided into four groups. The four groups underwent topography- and non-topography-guided PRK with sequential and simultaneous CXL. The main outcome measures were pre- and postoperative uncorrected distance visual acuity (UDVA), best corrected distance visual acuity (CDVA), manifest refraction, contrast sensitivity, and keratometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photorefractive keratectomy in mile keratoconus | Experimental | Procedure: Photorefractive keratectomy in mile keratoconusPhotorefractive keratectomy in mile keratoconus type of corneal surface ablation in for correct refractive error |
Who may qualify
- Ages
- 34 to 41 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 34 (range from 34 to 41)
- stable corneal topography and refraction for at least six months
- estimated residual bed thickness of >410 µm
Key exclusion criteria (12 listed)
- presence of macular or retinal disease,
- dry eye
- history of recurrent corneal erosions
- anterior segment abnormalities
- unstable refractive error
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 |
|---|---|---|
| Photorefractive keratectomy in mile keratoconusAlso: Advance surface abelation in mild keratoconusTopo-guided photorefractive keratectomy will be performed using an excimer laser (Allegretto Wave Topolyzer, Alcon, Inc.) with a 6 mm optical area and a transition area of 2 mm in all eyes. At that point, the partial topography-guided photorefractive keratectomy laser treatment will be finished. The arrangement will be to treat 70% of the cylindrical and spherical part to not surpass 50μm of stromal expulsion. The estimation of 50μm as the most extreme removal depth recommended by Kanellopoulos in Athens protocol will be chosen | Procedure or surgery | Photorefractive keratectomy in mile keratoconus |
Primary outcome
visual acuity
Time frame: 3 months
Visual acuity (VA) commonly refers to the clarity of vision
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
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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.
Jorge Alio, MD,PhD study chair
Division of Ophthalmology, Universidad Miguel Hernández, Alicante, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photorefractive keratectomy in mile keratoconus in people with Keratoconus, run by Shahid Beheshti University 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 3 inclusion and 12 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 Apr 2022. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity (time frame: 3 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 Apr 2022.