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

Cornea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04286620
• Other study ID #: LASIK complications
• Status: Not yet recruiting
• Start date: April 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2020
• Source: Assiut University
• Contact: Abdelrahman M Saad
• Phone: +201067895256
• Email: arabasdm.23[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2021
• Est. primary completion date: April 1, 2021
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Individuals who are scheduled for LASIK surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cornea

Intervention

Device:
• LASIK
Correcting errors of refraction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of Intra-operative and early post-operative complications of LASIK	Assessment of post-LASIK complications	Baseline