- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05014269
Phacoemulsification in Patients With Corneal Opacities
Phacoemulsification in Patients With Corneal Opacities Using Slit Illumination of the Surgical Microscope
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Corneal opacity is often encountered in patients seeking senile cataract surgery in developing countries. Corneal opacity impairs the intraoperative visualization during cataract surgery which increases the risk of copmlications.
Several techniques were described to enhance the intraoperative visualization such as the use of anterior endoscopy, chandeiler retroillumination, and anterior chamber endoillumination. All these techniques require costly instrumentation.
the aim of this study was to assess the feasibility of performing phacoemulsification using slit illumination of the surgical microscope without the need of additional instruments, and report the visual outcome.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- The presence of visually significant senile cataract.
- A recent history of progressive diminution of vision within few months.
- Stable density and size of a preexisting trachomatous corneal opacity that does not impair the pupil or lens visualization after pupillary dilatation.
Exclusion Criteria:
- History of trauma, infectious corneal ulcers, or intraocular surgery.
- Coexisting ocular diseases e.g. glaucoma, retinal detachment, and vitreous hemorrhage.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of intra-operative complications of phacoemulsification in eyes with corneal opacities using the slit ilumination of the surgical microscope.
Time Frame: 3 months
|
the frequency of the intraoperative complications of phacoemulsification in eyes with corneal opacities
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual outcome of phacoemulsification in eyes with corneal opacities
Time Frame: 3 months
|
meaurement of the change of the distance corrected visual acuity bafoer after phacoemulsification using Snellen chart
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- phacoemulsification surgery
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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