ASSESSMENT OF INTRA-OPERATIVE AND EARLY POST-OPERATIVE LASIK COMPLICATIONS

NCT ID: NCT04286620

Last Updated: 2020-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2021-06-01

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.

Conditions

Cornea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

LASIK

Correcting errors of refraction

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Individuals who are scheduled for LASIK surgery

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrahman Mohamed saad

House officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarek A Mohamed, Professor

Role: STUDY_DIRECTOR

Ophthalmology department, faculty of medicine, Assiut university hospital

Dalia M El-Sebity, Ass.prof.

Role: STUDY_DIRECTOR

Ophthalmology department, faculty of medicine, Assiut university hospital

Khaled A Mohammed, Ass.prof.

Role: STUDY_DIRECTOR

Ophthalmology department, faculty of medicine, Assiut university hospital

Central Contacts

Abdelrahman M Saad

Role: CONTACT

arabasdm.23@gmail.com

+201067895256

Other Identifiers

LASIK complications

Identifier Type: -

Identifier Source: org_study_id