Irregular AstigmatismNCT03140046
Visual Outcomes of Topography Guided Photorefractive Keratectomy (PRK) for Treatment of Patients With Irregular Cornea
A study testing photorefractive keratectomy (PRK) in people with Irregular Astigmatism, run by Assiut University at 1 site in Egypt.
Trial summary
Irregular astigmatism is one of the most serious and frequent complications of corneal refractive surgery and one of the worst sequelae of other forms of corneal surgery . It is also considered as one of common, serious complications of corneal injuries . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Irregular Astigmatism
- What is being tested?
- photorefractive keratectomy (PRK)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 1 Mar 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with irregular corneal astigmatism caused by:
- Trauma.
- Non - Central Corneal Scars.
- Previous corneal surgery.
- With No other abnormalities in the eye.
- Patient is willing to enter the study and sign a consent.
Who cannot join
- Patients with central corneal scars.
- Patients with central haze interfering with visual acuity.
- Patients with ectasia at corneal graft margins.
- Patients with irregular astigmatism caused by corneal ectasia or keratoconus.
- Patients had refractive surgery with ablations leaving a residual corneal thickness less than 250 μm.
Trial locations and contacts
1 site in 1 country.
About this study
Irregular astigmatism is one of the most serious and frequent complications of corneal refractive surgery and one of the worst sequelae of other forms of corneal surgery . It is also considered as one of common, serious complications of corneal injuries .
Spectacle correction is usually not useful in the correction of corneal irregular astigmatism. Contact lenses represent a good alternative, but their adaptation and stability are limited by the irregular corneal surface and patient discomfort.
Read more
In recent years, advancements in laser technology have offered better tools for dealing with irregular astigmatism with finding new surgical methods to improve corneal regularity for the correction of irregular astigmatism.
Topography-linked excimer laser is a potentially effective technique in the treatment of irregular astigmatism after keratoplasty . In fact, customized ablation was shown to be an effective means of treatment of irregular astigmatism due to different etiologies Such as corneal Injuries , scar , or postoperative.
Some of the theoretical advantages of topography-driven photorefractive keratectomy (PRK) are a better astigmatic correction, the possibility of correcting irregular astigmatism, and a smaller ablation volume compared with standard treatments, resulting in better visual performance.
Aim of the work To evaluate the efficacy, safety, and predictability of topography-guided photorefractive keratectomy (PRK) to improve refractive status of patient with irregular Cornea.
- Conditions
- Irregular Astigmatism
- Being tested
- photorefractive keratectomy (PRK)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photorefractive keratectomy (PRK)Procedure or surgery
Also called PRK
The cornea will be ablated while the patient fixating on target light under constant eye-tracking control. The ablations will be made using the "ALLEGRETTO X 500WAVE excimer laser" (WaveLight Laser Technologie AG).
| Study group | Role | What they receive |
|---|---|---|
| Corneal Topography | Experimental | we will do Corneal Topography for every patient before doing photorefractive keratectomy (PRK) and also after it , to measure the change in the quality of vision and measure the change in the quality of vision Receives: Procedure: photorefractive keratectomy (PRK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
The measure of the Visual Acuity and Best Corrected Visual acuity Using the Snellen Chart which give use an idea about visual acuity in Metric scale (e.g. 6\6 , 6\12)
Measured: follow up after 1 day, 1 week, 1 month and 3 months
Secondary outcomes (1)
Refractive State
We will measure the Refractive state of the eye by using the Auto refractor which give us an idea about the refractive state in a Diopteric scale ( e.g. -2D , +4 D) .
Measured: follow up after 1 day, 1 week, 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start1 Mar 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irregular AstigmatismStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelsamee Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140046
- Sponsor's protocol ID
- PRK
- Status last verified
- May 2020
- First submitted
- 26 Apr 2017
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes of Topography Guided Photorefractive Keratectomy (PRK) for Treatment of Patients With Irregular Cornea
- ClinicalTrials.gov ID
- NCT03140046
- Acronym / sponsor ID
- PRK
- Conditions
- Irregular Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 4 May 2017 (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.
Irregular astigmatism is one of the most serious and frequent complications of corneal refractive surgery and one of the worst sequelae of other forms of corneal surgery . It is also considered as one of common, serious complications of corneal injuries .
Spectacle correction is usually not useful in the correction of corneal irregular astigmatism. Contact lenses represent a good alternative, but their adaptation and stability are limited by the irregular corneal surface and patient discomfort.
In recent years, advancements in laser technology have offered better tools for dealing with irregular astigmatism with finding new surgical methods to improve corneal regularity for the correction of irregular astigmatism.
Topography-linked excimer laser is a potentially effective technique in the treatment of irregular astigmatism after keratoplasty . In fact, customized ablation was shown to be an effective means of treatment of irregular astigmatism due to different etiologies Such as corneal Injuries , scar , or postoperative.
Some of the theoretical advantages of topography-driven photorefractive keratectomy (PRK) are a better astigmatic correction, the possibility of correcting irregular astigmatism, and a smaller ablation volume compared with standard treatments, resulting in better visual performance.
Aim of the work To evaluate the efficacy, safety, and predictability of topography-guided photorefractive keratectomy (PRK) to improve refractive status of patient with irregular Cornea.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corneal Topography | Experimental | Procedure: photorefractive keratectomy (PRK)we will do Corneal Topography for every patient before doing photorefractive keratectomy (PRK) and also after it , to measure the change in the quality of vision and measure the change in the quality of vision |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with irregular corneal astigmatism caused by:
- With No other abnormalities in the eye.
- Patient is willing to enter the study and sign a consent.
Key exclusion criteria (5 listed)
- Patients with central corneal scars.
- Patients with central haze interfering with visual acuity.
- Patients with ectasia at corneal graft margins.
- Patients with irregular astigmatism caused by corneal ectasia or keratoconus.
- Patients had refractive surgery with ablations leaving a residual corneal thickness less than 250 μm.
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 (PRK)Also: PRKThe cornea will be ablated while the patient fixating on target light under constant eye-tracking control. The ablations will be made using the "ALLEGRETTO X 500WAVE excimer laser" (WaveLight Laser Technologie AG). | Procedure or surgery | Corneal Topography |
Primary outcome
Visual Acuity
Time frame: follow up after 1 day, 1 week, 1 month and 3 months
The measure of the Visual Acuity and Best Corrected Visual acuity Using the Snellen Chart which give use an idea about visual acuity in Metric scale (e.g. 6\6 , 6\12)
1 secondary outcome
Refractive State
Time frame: follow up after 1 day, 1 week, 1 month and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Individual participant dataSharing planned: No
Related trials for Irregular Astigmatism
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Intrastromal Fresh Human Corneal Lenticule Implantation Using Smile Surgery for Treatment of Irregular Corneal Astigmatism After Penetrating Keratoplasty (New Approach)
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Improving Visual Quality in Patients With Irregular Corneas Using Asymmetrical Toric Intraocular Lenses
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Effect of Corneal and Scleral RGP Lenses on Ocular Health and Visual Quality in Keratoconus
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (PRK) in people with Irregular Astigmatism, run by Assiut University at 1 site in Egypt.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 11 May 2020. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: follow up after 1 day, 1 week, 1 month and 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 11 May 2020.