NCT04333069

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

April 10, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

April 3, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

March 28, 2020

Last Update Submit

April 1, 2020

Conditions

Keywords

uveitis

Outcome Measures

Primary Outcomes (8)

  • final postoperative uncorrected visual acuity (UCVA)

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

    1 week post operative

  • final postoperative uncorrected visual acuity (UCVA)

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

    1month post operative

  • final postoperative uncorrected visual acuity (UCVA)

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

    3months post operative

  • final postoperative uncorrected visual acuity (UCVA)

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

    6months post operative

  • Final post operative best corrected visual acuity (BCVA)

    Post operative visual acuity with spectacle correction

    1 week post operative

  • Final post operative best corrected visual acuity (BCVA)

    Post operative visual acuity with spectacle correction

    1month post operative

  • Final post operative best corrected visual acuity (BCVA)

    Post operative visual acuity with spectacle correction

    3months post operative

  • Final post operative best corrected visual acuity (BCVA)

    Post operative visual acuity with spectacle correction

    6months post operative

Secondary Outcomes (2)

  • incidence of postoperative complications

    6 months post operative

  • Reactivation of intraocular inflammation

    6 months post operative

Study Arms (1)

Uncorrected and best corrected visual acuity

OTHER

Measuring of uncorrected and best corrected visual acuity after phaco emulsification and irrigation aspiration cataract surgery

Procedure: cataract surgery

Interventions

cataract surgery in form of phaco emulsification or irrigation aspiration

Uncorrected and best corrected visual acuity

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 32157612BACKGROUND
  • 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.

    PMID: 31788579BACKGROUND
  • 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.

    PMID: 30900580BACKGROUND
  • 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.

    PMID: 30574896BACKGROUND
  • 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.

    PMID: 30203671BACKGROUND

MeSH Terms

Conditions

CataractUveitis

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesUveal Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ashraf Khalaf Al Husseini, professor

    Assiut University

    STUDY DIRECTOR
  • Wael Mohammed Ahmed Soliman, professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mona Abdallah Abd AlRazik Ahmed, MD

CONTACT

Mohammed Gamal Saleh, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer at Ophthalmology departmentAssiut University Faculty of Medicine

Study Record Dates

First Submitted

March 28, 2020

First Posted

April 3, 2020

Study Start

April 10, 2020

Primary Completion

May 20, 2022

Study Completion

December 20, 2022

Last Updated

April 3, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share