Outcome of Cataract Surgery With Uveitis
Primary Purpose
Cataract; Complicata
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cataract surgery
Sponsored by
About this trial
This is an interventional screening trial for Cataract; Complicata focused on measuring uveitis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Uncorrected and best corrected visual acuity
Arm Description
Measuring of uncorrected and best corrected visual acuity after phaco emulsification and irrigation aspiration cataract surgery
Outcomes
Primary Outcome Measures
final postoperative uncorrected visual acuity (UCVA)
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
final postoperative uncorrected visual acuity (UCVA)
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
final postoperative uncorrected visual acuity (UCVA)
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
final postoperative uncorrected visual acuity (UCVA)
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
Final post operative best corrected visual acuity (BCVA)
Post operative visual acuity with spectacle correction
Final post operative best corrected visual acuity (BCVA)
Post operative visual acuity with spectacle correction
Final post operative best corrected visual acuity (BCVA)
Post operative visual acuity with spectacle correction
Final post operative best corrected visual acuity (BCVA)
Post operative visual acuity with spectacle correction
Secondary Outcome Measures
incidence of postoperative complications
cystoid macular edema which mean inflammation, swelling and collection of fluid inside macula) .
Reactivation of intraocular inflammation
Appearance of inflammatory activity inside the eye after period of quiescence of at least 6 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04333069
Brief Title
Outcome of Cataract Surgery With Uveitis
Official Title
Outcome of Cataract Surgery in Patient With Uveitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2020 (Anticipated)
Primary Completion Date
May 20, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract; Complicata
Keywords
uveitis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Uncorrected and best corrected visual acuity
Arm Type
Other
Arm Description
Measuring of uncorrected and best corrected visual acuity after phaco emulsification and irrigation aspiration cataract surgery
Intervention Type
Procedure
Intervention Name(s)
cataract surgery
Intervention Description
cataract surgery in form of phaco emulsification or irrigation aspiration
Primary Outcome Measure Information:
Title
final postoperative uncorrected visual acuity (UCVA)
Description
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
Time Frame
1 week post operative
Title
final postoperative uncorrected visual acuity (UCVA)
Description
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
Time Frame
1month post operative
Title
final postoperative uncorrected visual acuity (UCVA)
Description
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
Time Frame
3months post operative
Title
final postoperative uncorrected visual acuity (UCVA)
Description
post operative uncorrected visual acuity which mean visual acuity without spectacle correction
Time Frame
6months post operative
Title
Final post operative best corrected visual acuity (BCVA)
Description
Post operative visual acuity with spectacle correction
Time Frame
1 week post operative
Title
Final post operative best corrected visual acuity (BCVA)
Description
Post operative visual acuity with spectacle correction
Time Frame
1month post operative
Title
Final post operative best corrected visual acuity (BCVA)
Description
Post operative visual acuity with spectacle correction
Time Frame
3months post operative
Title
Final post operative best corrected visual acuity (BCVA)
Description
Post operative visual acuity with spectacle correction
Time Frame
6months post operative
Secondary Outcome Measure Information:
Title
incidence of postoperative complications
Description
cystoid macular edema which mean inflammation, swelling and collection of fluid inside macula) .
Time Frame
6 months post operative
Title
Reactivation of intraocular inflammation
Description
Appearance of inflammatory activity inside the eye after period of quiescence of at least 6 months
Time Frame
6 months post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mona Abdallah Abd AlRazik Ahmed, MD
Phone
01014398129
Email
monaabdallah51290@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Gamal Saleh, lecturer
Phone
01004530716
Email
mgsaleh05@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf Khalaf Al Husseini, professor
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wael Mohammed Ahmed Soliman, professor
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32157612
Citation
Carpentier SJ, Jung JL, Patnaik JL, Pecen PE, Palestine AG. A Cross-Sectional Online Survey Identifies Subspecialty Differences in the Management of Pediatric Cataracts Associated with Uveitis. Ophthalmol Ther. 2020 Jun;9(2):293-303. doi: 10.1007/s40123-020-00245-x. Epub 2020 Mar 10.
Results Reference
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PubMed Identifier
31788579
Citation
Chen JL, Bhat P, Lobo-Chan AM. Perioperative Management of Uveitic Cataracts. Adv Ophthalmol Optom. 2019 Aug;4:325-339. doi: 10.1016/j.yaoo.2019.04.014. Epub 2019 May 18.
Results Reference
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PubMed Identifier
30900580
Citation
Yangzes S, Seth NG, Singh R, Gupta PC, Jinagal J, Pandav SS, Gupta V, Gupta A, Ram J. Long-term outcomes of cataract surgery in children with uveitis. Indian J Ophthalmol. 2019 Apr;67(4):490-495. doi: 10.4103/ijo.IJO_846_18.
Results Reference
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PubMed Identifier
30574896
Citation
Jinagal J, Gupta G, Agarwal A, Aggarwal K, Akella M, Gupta V, Suri D, Gupta A, Singh S, Ram J. Safety and efficacy of dexamethasone implant along with phacoemulsification and intraocular lens implantation in children with juvenile idiopathic arthritis associated uveitis. Indian J Ophthalmol. 2019 Jan;67(1):69-74. doi: 10.4103/ijo.IJO_713_18.
Results Reference
background
PubMed Identifier
30203671
Citation
El Gharbawy SA, Darwish EA, Abu Eleinen KG, Osman MH. Efficacy of addition of nepafenac 0.1% to steroid eye drops in prevention of post-phaco macular edema in high-risk eyes. Eur J Ophthalmol. 2019 Jul;29(4):453-457. doi: 10.1177/1120672118799626. Epub 2018 Sep 11.
Results Reference
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Outcome of Cataract Surgery With Uveitis
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