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

NCT ID: NCT06759597

Last Updated: 2025-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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Neovascular (wet) Age-Related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Demiana alkes zakka labib

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Demiana Alkes Zakka Labib Demiana Alkes Zakka Labib

Role: CONTACT

+01211418560

Other Identifiers

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Macular Changes after PHE

Identifier Type: -

Identifier Source: org_study_id

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