Clinical trial NCT04333069: Outcome of Cataract Surgery With Uveitis
Official title: Outcome of Cataract Surgery in Patient With Uveitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract; Complicata
Keywords: uveitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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

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.

Primary outcomes:
measure: final postoperative uncorrected visual acuity (UCVA)
timeFrame: 1 week post operative
measure: final postoperative uncorrected visual acuity (UCVA)
timeFrame: 1month post operative
measure: final postoperative uncorrected visual acuity (UCVA)
timeFrame: 3months post operative
measure: final postoperative uncorrected visual acuity (UCVA)
timeFrame: 6months post operative
measure: Final post operative best corrected visual acuity (BCVA)
timeFrame: 1 week post operative
measure: Final post operative best corrected visual acuity (BCVA)
timeFrame: 1month post operative
measure: Final post operative best corrected visual acuity (BCVA)
timeFrame: 3months post operative
measure: Final post operative best corrected visual acuity (BCVA)
timeFrame: 6months post operative
Secondary outcomes:
measure: incidence of postoperative complications
timeFrame: 6 months post operative
measure: Reactivation of intraocular inflammation
timeFrame: 6 months post operative
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ashraf Khalaf Al Husseini, professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Wael Mohammed Ahmed Soliman, professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.