Outcome of Cataract Surgery With Uveitis

Cataract; Complicata Clinical Trial

Official title:

Outcome of Cataract Surgery in Patient With Uveitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04333069
• Other study ID #: cat in uveitic patients
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 10, 2020
• Est. completion date: December 20, 2022

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: Mona Abdallah Abd AlRazik Ahmed, MD
• Phone: 01014398129
• Email: monaabdallah51290[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract; Complicata
• Uveitis

Intervention

Procedure:
• cataract surgery
cataract surgery in form of phaco emulsification or irrigation aspiration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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 Mar 10. doi: 10.1007/s40123-020-00245-x. [Epub ahead of print] — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	final postoperative uncorrected visual acuity (UCVA)	post operative uncorrected visual acuity which mean visual acuity without spectacle correction	1 week post operative
Primary	final postoperative uncorrected visual acuity (UCVA)	post operative uncorrected visual acuity which mean visual acuity without spectacle correction	1month post operative
Primary	final postoperative uncorrected visual acuity (UCVA)	post operative uncorrected visual acuity which mean visual acuity without spectacle correction	3months post operative
Primary	final postoperative uncorrected visual acuity (UCVA)	post operative uncorrected visual acuity which mean visual acuity without spectacle correction	6months post operative
Primary	Final post operative best corrected visual acuity (BCVA)	Post operative visual acuity with spectacle correction	1 week post operative
Primary	Final post operative best corrected visual acuity (BCVA)	Post operative visual acuity with spectacle correction	1month post operative
Primary	Final post operative best corrected visual acuity (BCVA)	Post operative visual acuity with spectacle correction	3months post operative
Primary	Final post operative best corrected visual acuity (BCVA)	Post operative visual acuity with spectacle correction	6months post operative
Secondary	incidence of postoperative complications	cystoid macular edema which mean inflammation, swelling and collection of fluid inside macula) .	6 months post operative
Secondary	Reactivation of intraocular inflammation	Appearance of inflammatory activity inside the eye after period of quiescence of at least 6 months	6 months post operative