Outcome of Cataract Surgery With Uveitis

April 1, 2020 updated by: Mona Abdallah Abdal Razik Ahmed, Assiut University

Outcome of Cataract Surgery in Patient With Uveitis

Aim of the study is to evaluate outcome of cataract surgery in different types of uveitis as regarding best corrected visual acuity (BCVA) and rate of post operative complications.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Cataract is the main cause of reversible blindness in patients with uveitis. Cataract occurs in up to 50% to 70% of patients with uveitis.

Preoperative complications, including anterior synechiae, posterior synechiae, and pupillary membrane formation, may increase surgical challenges. In addition, recurrent inflammation increases the incidence of postoperative complications and often affects the visual prognosis. In recent years, phacoemulsification with intra ocular lens (IOL)implantation has become the main surgical method for treating uveitis (complicated cataract), and the visual prognosis of patients who undergo this procedure is usually favorable.

Surgical treatment may be effective but is associated with higher rates of complication than in non uveitic eyes. Cystoid macular edema (CME) is the most common complication cataract surgery in the general population. Although, in most cases, the macular edema is self-limited, in rare cases it can lead to long-term visual deterioration that is difficult to treat.

Another common complication after cataract surgery is posterior capsule opacification (PCO) , leading to symptoms of glare or blurred vision, reduced visual acuity, or impaired posterior segment exam. Factors that are critical in the development of PCO include surgical technique, type of implanted intra ocular lens (IOL) either foldable hydrophilic acrylic, hydrophobic acrylic or silicone and postoperative control of uveitis

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Visually significant cataract ( means opacification of the crystalline lens adequate to interfere with vision)in patients with uveitis controlled for at least 1month.

Exclusion Criteria:

  • Irreversible pathology affecting outcome e.g. macular scar ,optic atrophy, and retinal detachment.
  • Patients with active uveitis (means inflammation inside the eye).
  • Patients less than 16 years old.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Uncorrected and best corrected visual acuity
Measuring of uncorrected and best corrected visual acuity after phaco emulsification and irrigation aspiration cataract surgery
Procedure: cataract surgery
cataract surgery in form of phaco emulsification or irrigation aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
final postoperative uncorrected visual acuity (UCVA)
Time Frame: 1 week post operative
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
1 week post operative
final postoperative uncorrected visual acuity (UCVA)
Time Frame: 1month post operative
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
1month post operative
final postoperative uncorrected visual acuity (UCVA)
Time Frame: 3months post operative
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
3months post operative
final postoperative uncorrected visual acuity (UCVA)
Time Frame: 6months post operative
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
6months post operative
Final post operative best corrected visual acuity (BCVA)
Time Frame: 1 week post operative
Post operative visual acuity with spectacle correction
1 week post operative
Final post operative best corrected visual acuity (BCVA)
Time Frame: 1month post operative
Post operative visual acuity with spectacle correction
1month post operative
Final post operative best corrected visual acuity (BCVA)
Time Frame: 3months post operative
Post operative visual acuity with spectacle correction
3months post operative
Final post operative best corrected visual acuity (BCVA)
Time Frame: 6months post operative
Post operative visual acuity with spectacle correction
6months post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of postoperative complications
Time Frame: 6 months post operative
cystoid macular edema which mean inflammation, swelling and collection of fluid inside macula) .
6 months post operative
Reactivation of intraocular inflammation
Time Frame: 6 months post operative
Appearance of inflammatory activity inside the eye after period of quiescence of at least 6 months
6 months post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Ashraf Khalaf Al Husseini, professor, Assiut University
  • Principal Investigator: Wael Mohammed Ahmed Soliman, professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 10, 2020

Primary Completion (Anticipated)

May 20, 2022

Study Completion (Anticipated)

December 20, 2022

Study Registration Dates

First Submitted

March 28, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cat in uveitic patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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