Outcome of Cataract Surgery With Uveitis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04333069
Collaborator
(none)
50
1
32.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: cataract surgery
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Outcome of Cataract Surgery in Patient With Uveitis
Anticipated Study Start Date :
Apr 10, 2020
Anticipated Primary Completion Date :
May 20, 2022
Anticipated Study Completion Date :
Dec 20, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. final postoperative uncorrected visual acuity (UCVA) [1 week post operative]

    post operative uncorrected visual acuity which mean visual acuity without spectacle correction

  2. final postoperative uncorrected visual acuity (UCVA) [1month post operative]

    post operative uncorrected visual acuity which mean visual acuity without spectacle correction

  3. final postoperative uncorrected visual acuity (UCVA) [3months post operative]

    post operative uncorrected visual acuity which mean visual acuity without spectacle correction

  4. final postoperative uncorrected visual acuity (UCVA) [6months post operative]

    post operative uncorrected visual acuity which mean visual acuity without spectacle correction

  5. Final post operative best corrected visual acuity (BCVA) [1 week post operative]

    Post operative visual acuity with spectacle correction

  6. Final post operative best corrected visual acuity (BCVA) [1month post operative]

    Post operative visual acuity with spectacle correction

  7. Final post operative best corrected visual acuity (BCVA) [3months post operative]

    Post operative visual acuity with spectacle correction

  8. Final post operative best corrected visual acuity (BCVA) [6months post operative]

    Post operative visual acuity with spectacle correction

Secondary Outcome Measures

  1. incidence of postoperative complications [6 months post operative]

    cystoid macular edema which mean inflammation, swelling and collection of fluid inside macula) .

  2. Reactivation of intraocular inflammation [6 months post operative]

    Appearance of inflammatory activity inside the eye after period of quiescence of at least 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mona Abdallah Abdal Razik Ahmed, Assistant lecturer at Ophthalmology departmentAssiut University Faculty of Medicine, Assiut University
ClinicalTrials.gov Identifier:
NCT04333069
Other Study ID Numbers:
  • cat in uveitic patients
First Posted:
Apr 3, 2020
Last Update Posted:
Apr 3, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mona Abdallah Abdal Razik Ahmed, Assistant lecturer at Ophthalmology departmentAssiut University Faculty of Medicine, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 3, 2020