Clinical trial NCT04286620: ASSESSMENT OF INTRA-OPERATIVE AND EARLY POST-OPERATIVE LASIK COMPLICATIONS
Official title: ASSESSMENT OF INTRA-OPERATIVE AND EARLY POST-OPERATIVE LASIK COMPLICATIONS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cornea
Keywords: LASIK complications
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Individuals who are scheduled for LASIK surgery

Exclusion Criteria:

* history of previous ocular surgery, and inadequate follow up.

Primary outcomes:
measure: Identification of Intra-operative and early post-operative complications of LASIK
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ophthalmology department, faculty of medicine, Assiut university hospital
name: Tarek A Mohamed, Professor
role: STUDY_DIRECTOR
affiliation: Ophthalmology department, faculty of medicine, Assiut university hospital
name: Dalia M El-Sebity, Ass.prof.
role: STUDY_DIRECTOR
affiliation: Ophthalmology department, faculty of medicine, Assiut university hospital
name: Khaled A Mohammed, Ass.prof.
role: STUDY_DIRECTOR
References: