The Effect of Phacoemulsification on the Macular Changes in Patients with Neovascular Age-related Macular Degeneration

Not yet recruiting

• Conditions: Neovascular (wet) Age-Related Macular Degeneration

• Registration Number: NCT06759597
• Lead Sponsor: Assiut University

Brief Summary

The macula has a very high concentration of photoreceptor cells - the cells that detect light. They send signals to the brain, which interprets them as images. The rest of the retina processes our peripheral, or side vision To explore whether cataract surgery evokes development or relapse of choroidal neovascularization (CNV) in wet age-related macular degeneration (AMD) patients followed for a 1-year postoperative period

Detailed Description

Age-related macular degeneration (AMD) is a leading cause of vision loss in adults over the age of 50. AMD causes damage to a small part of the retina responsible for central vision called the macula. When damage to the macula occurs, it typically causes loss of central, detailed vision which results in difficulty with tasks such as reading, driving, threading a needle, or recognizing faces.

Phacoemulsification is a modern-day cataract surgery that employs ultrasound energy to emulsify the nucleus, vacuum to catch the nuclear material, and irrigation and aspiration for cortex and viscoelastic removal.

It is currently impossible to draw definitive conclusions whether phacoemulsification (PhE) is safe for people with age-related macular degeneration (ARMD). It is not clear if PhE causes the progression of ARMD and affects visual acuity (VA). The purpose was to analyze the possible association of PhE with ARMD progression in the early and late (up to 18 months after surgery) period.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Study Start: 2025-02-01
• Primary Completion: 2026-02
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Subjects included in this study aged above 50 and presented for routine check up after undergoing phacoemulsification:

• Above 50 years old

  • not diabetic individuals
  • wet ARMD

Exclusion Criteria

• intraoperative complications

  • Eyes with diseases predisposing them for postoperative macular edema, preexisting macular edema, and eyes that developed cystoid macular edema
  • active ocular inflammation or infection _glaucoma
  • A preoperatively worsened VA regardless phE
  • ocular trauma
  • patients with central retinal ischemia
  • previous vitrectomy
  • dry amd

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To figure out the possibility of Postoperative conversion or relapse ( Dry to wet , wet to reactivated CNV)	baseline	To explore whether cataract surgery evokes development or relapse of choroidal neovascularization (CNV) in wet age-related macular degeneration (AMD) patients followed for a 1-year postoperative period