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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04286620
Collaborator
(none)
100
14

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: LASIK

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

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
ASSESSMENT OF INTRA-OPERATIVE AND EARLY POST-OPERATIVE LASIK COMPLICATIONS
Anticipated Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Identification of Intra-operative and early post-operative complications of LASIK [Baseline]

    Assessment of post-LASIK complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Individuals who are scheduled for LASIK surgery
Exclusion Criteria:
  • history of previous ocular surgery, and inadequate follow up.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Tarek A Mohamed, Professor, Ophthalmology department, faculty of medicine, Assiut university hospital
  • Study Director: Dalia M El-Sebity, Ass.prof., Ophthalmology department, faculty of medicine, Assiut university hospital
  • Study Director: Khaled A Mohammed, Ass.prof., Ophthalmology department, faculty of medicine, Assiut university hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abdelrahman Mohamed saad, House officer, Assiut University
ClinicalTrials.gov Identifier:
NCT04286620
Other Study ID Numbers:
  • LASIK complications
First Posted:
Feb 27, 2020
Last Update Posted:
Feb 27, 2020
Last Verified:
Feb 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Abdelrahman Mohamed saad, House officer, Assiut University

Study Results

No Results Posted as of Feb 27, 2020