CorneaNCT04286620
ASSESSMENT OF INTRA-OPERATIVE AND EARLY POST-OPERATIVE LASIK COMPLICATIONS
An observational study of Cornea, run by Assiut University.
Trial summary
To discuss the prevalence of intra-operative and early post-operative complications of LASIK among individuals who underwent LASIK procedure and review the symptoms, findings, and management options. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cornea
- What is being tested?
- LASIK
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Jun 2021
- Phase
- Observational
- 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
- Child, Adult, Older adult
Study population: Parameters to be included: demographic data, history, symptoms, post-operative uncorrected and best corrected visual acuities, examination findings, and treatment recommendations. Documentation of complications.
Who may be able to join
- Individuals who are scheduled for LASIK surgery
Who cannot join
- history of previous ocular surgery, and inadequate follow up.
Trial locations and contacts
No sites are listed yet.
About this study
To discuss the prevalence of intra-operative and early post-operative complications of LASIK among individuals who underwent LASIK procedure and review the symptoms, findings, and management options.
Read the detailed description
In recent years, a number of possible surgical procedures in ophthalmology has offered patients an alternative to spectacles or contact lenses. Several laser and non-laser refractive surgical procedures have been used to modify the shape of the cornea and correct myopia, hyperopia, astigmatism, and presbyopia. Introduction of the excimer laser to reshape the cornea has resulted in remarkable developments in the correction of refractive errors. Combined with other advanced ophthalmic instruments, laser refractive eye surgery has resulted in a substantial increase in the safety, efficacy, and predictability of surgical outcomes.
Refractive surgery has enabled individuals to enter occupations they were previously precluded from due to their vision.Laser in situ keratomileusis (LASIK) surgery is one of the most common surgeries performed worldwide to correct refractive errors and reduce dependence on eyeglasses or contact lenses. In addition, patient satisfaction following LASIK is commonly reported as high and studies of the visual and refractive outcome of LASIK for the treatment of myopia and astigmatism have reported great success.
LASIK, compared to photorefractive keratectomy (PRK), has low postoperative discomfort, early visual rehabilitation and decreased postoperative haze. LASIK involves an additional procedure of creating a corneal flap. This may result in complications related to the flap, interface and underlying stromal bed. The common flap-related complications include thin flap, button holing, free caps, flap dislocation, torn flap, incomplete cut, and flap striae. The interface complications of diffuse lamellar keratitis, epithelial ingrowth and microbial keratitis are potentially sight threatening. After LASIK, there is a long period of sensory denervation leading to the complication of dry eyes. The refractive complications include under-correction, over-correction, regression, irregular astigmatism, and visual aberrations.
- Conditions
- Cornea
- Being tested
- LASIK
- Keywords
- LASIK complications
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIKDevice
Correcting errors of refraction
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Intra-operative and early post-operative complications of LASIK
Assessment of post-LASIK complications
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CorneaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohamed saad, Assiut University
- Investigators
- Tarek A Mohamed, Professor, Study director, Ophthalmology department, faculty of medicine, Assiut university hospitalDalia M El-Sebity, Ass.prof., Study director, Ophthalmology department, faculty of medicine, Assiut university hospitalKhaled A Mohammed, Ass.prof., Study director, Ophthalmology department, faculty of medicine, Assiut university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286620
- Sponsor's protocol ID
- LASIK complications
- Status last verified
- Feb 2020
- First submitted
- 25 Feb 2020
- Last updated
- 27 Feb 2020
- 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 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF INTRA-OPERATIVE AND EARLY POST-OPERATIVE LASIK COMPLICATIONS
- ClinicalTrials.gov ID
- NCT04286620
- Acronym / sponsor ID
- LASIK complications
- Conditions
- Cornea
- Keywords
- LASIK complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 27 Feb 2020 (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 discuss the prevalence of intra-operative and early post-operative complications of LASIK among individuals who underwent LASIK procedure and review the symptoms, findings, and management options.
Detailed description
In recent years, a number of possible surgical procedures in ophthalmology has offered patients an alternative to spectacles or contact lenses. Several laser and non-laser refractive surgical procedures have been used to modify the shape of the cornea and correct myopia, hyperopia, astigmatism, and presbyopia. Introduction of the excimer laser to reshape the cornea has resulted in remarkable developments in the correction of refractive errors. Combined with other advanced ophthalmic instruments, laser refractive eye surgery has resulted in a substantial increase in the safety, efficacy, and predictability of surgical outcomes.
Refractive surgery has enabled individuals to enter occupations they were previously precluded from due to their vision.Laser in situ keratomileusis (LASIK) surgery is one of the most common surgeries performed worldwide to correct refractive errors and reduce dependence on eyeglasses or contact lenses. In addition, patient satisfaction following LASIK is commonly reported as high and studies of the visual and refractive outcome of LASIK for the treatment of myopia and astigmatism have reported great success.
LASIK, compared to photorefractive keratectomy (PRK), has low postoperative discomfort, early visual rehabilitation and decreased postoperative haze. LASIK involves an additional procedure of creating a corneal flap. This may result in complications related to the flap, interface and underlying stromal bed. The common flap-related complications include thin flap, button holing, free caps, flap dislocation, torn flap, incomplete cut, and flap striae. The interface complications of diffuse lamellar keratitis, epithelial ingrowth and microbial keratitis are potentially sight threatening. After LASIK, there is a long period of sensory denervation leading to the complication of dry eyes. The refractive complications include under-correction, over-correction, regression, irregular astigmatism, and visual aberrations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Parameters to be included: demographic data, history, symptoms, post-operative uncorrected and best corrected visual acuities, examination findings, and treatment recommendations. Documentation of complications.
Key inclusion criteria (1 listed)
- Individuals who are scheduled for LASIK surgery
Key exclusion criteria (1 listed)
- history of previous ocular surgery, and inadequate follow up.
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 |
|---|---|---|
| LASIKCorrecting errors of refraction | Device | – |
Primary outcome
Identification of Intra-operative and early post-operative complications of LASIK
Time frame: Baseline
Assessment of post-LASIK complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
Related trials for Cornea
Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
Fuchs, Fuchs Dystrophy
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
Not yet recruiting
A Single-Center Clinical Study Evaluating the Efficacy and Safety of Allogeneic Natural Killer (NK) Cell Transplantation for Mooren's Ulcer
Cornea Disease
Recruiting
4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
Corneal Diseases, Retinal Diseases
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.
Tarek A Mohamed, Professor study director
Ophthalmology department, faculty of medicine, Assiut university hospital
Dalia M El-Sebity, Ass.prof. study director
Ophthalmology department, faculty of medicine, Assiut university hospital
Khaled A Mohammed, Ass.prof. study director
Ophthalmology department, faculty of medicine, Assiut university hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cornea, run by Assiut University.
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 1 inclusion and 1 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 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Abdelrahman M Saad (+201067895256, arabasdm.23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Intra-operative and early post-operative complications of LASIK (time frame: Baseline). 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 27 Feb 2020.