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Anterior Chamber Illumination in Cataract Surgery for Eyes With Poor Red Reflex

Primary Purpose

Cataract Senile

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Anterior chamber illumination in cataract surgery
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Senile

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • cataract with poor red reflex

Exclusion Criteria:

  • Eyes that had previous intraocular surgery or trauma were excluded.

Sites / Locations

  • Alexandria university

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

cataract patients with poor red reflex

Arm Description

included cataract patients with poor red reflex

Outcomes

Primary Outcome Measures

number of patients with completion of the capsulorhexis and in-the-bag implantation of an intraocular lens
number of patients with completion of the capsulorhexis and in-the-bag implantation of an intraocular lens

Secondary Outcome Measures

Full Information

First Posted
January 3, 2020
Last Updated
January 6, 2020
Sponsor
University of Alexandria
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1. Study Identification

Unique Protocol Identification Number
NCT04220138
Brief Title
Anterior Chamber Illumination in Cataract Surgery for Eyes With Poor Red Reflex
Official Title
Anterior Chamber Illumination in Cataract Surgery for Eyes With Poor Red Reflex
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
With a poor red reflex, it is difficult to see the anterior capsule and continuous curvilinear capsulorhexis (CCC) margin, sometimes resulting in decentered CCC or radial tearing of the anterior capsule. In addition, other complications, such as rupture of the posterior capsule, dropping of the lens nucleus, or zonular dialysis, can occur during phacoemulsification because of poor visualization of the posterior capsule. These complications also increase the time of surgery and may affect the results of the vitrectomy.
Detailed Description
Several surgical techniques have been used to alleviate the problem of poor lens visibility. fixed a chandelier illuminator on the sclera, turned off the microscope light source, and visualized the lens by illuminating the vitreous cavity. Furino improved anterior lens capsule visibility by staining it with triamcinolone acetonide. Although both techniques were effective, both had limitations. Vitreous chamber illumination reduces the visibility of the cornea and iris because of the need to turn off the microscope light. Staining the anterior lens capsule with triamcinolone acetonide allows for better anterior chamber visualization but the lenticular nucleus and cortex remain difficult to see. This will be a prospective interventional case series, patients with cataract and poor red reflex will undergo phacoemulsification assisted by anterior chamber illumination to overcome the problem of poor red reflex.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Senile

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cataract patients with poor red reflex
Arm Type
Other
Arm Description
included cataract patients with poor red reflex
Intervention Type
Procedure
Intervention Name(s)
Anterior chamber illumination in cataract surgery
Intervention Description
This will be a prospective interventional case series, patients with cataract and poor red reflex will undergo phacoemulsification assisted by anterior chamber illumination to overcome the problem of poor red reflex.
Primary Outcome Measure Information:
Title
number of patients with completion of the capsulorhexis and in-the-bag implantation of an intraocular lens
Description
number of patients with completion of the capsulorhexis and in-the-bag implantation of an intraocular lens
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: cataract with poor red reflex Exclusion Criteria: Eyes that had previous intraocular surgery or trauma were excluded.
Facility Information:
Facility Name
Alexandria university
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
data of the patients are available to other researchers upon request
IPD Sharing Time Frame
after publishing

Learn more about this trial

Anterior Chamber Illumination in Cataract Surgery for Eyes With Poor Red Reflex

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