Evaluation of Vitreous Modifications After Cataract Surgery

NCT07816887 | Recruiting FDA Device

• 1 other identifier: 05072026
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate changes in vitreous structure and the vitreoretinal interface following cataract surgery using spectral-domain optical coherence tomography (OCT). Patients undergoing cataract surgery will undergo standardized OCT imaging before and after surgery. Preoperative and postoperative images will be compared to identify and characterize qualitative and quantitative changes in vitreous morphology, with particular attention to the posterior vitreous and its relationship with the retinal surface.

Conditions

Vitreous Detachment; Cataract (Post-operative Cataract Surgery Follow-up)

Keywords

vitreous detachment; post-operative cataracte surgery

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Postoperative Changes in Vitreous Morphology or Vitreoretinal Interface Configuration

  Preoperative and postoperative OCT images will be compared to identify participants showing structural changes in the posterior vitreous or vitreoretinal interface, including changes in posterior hyaloid position, vitreoretinal attachment status, and the development of partial or complete posterior vitreous detachment (PVD). Results will be reported as the number and proportion of participants presenting these postoperative changes.

  4 weeks

Study Arms (1)

No vitreous detachment

Patients scheduled for cataract surgery without posterior vitreous detachment

Procedure: cataract surgery

Interventions

cataract surgery PROCEDURE

standard cataracte surgery

No vitreous detachment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for cataract surgery without posterior vitreous detachment

You may qualify if:

• Presence of cataract scheduled for surgery
• Adequate image acquisition quality
• Absence of posterior vitreous detachment (PVD)
• Availability of both preoperative and postoperative OCT imaging

You may not qualify if:

• Advanced cataract significantly compromising image quality
• Presence of posterior vitreous detachment (PVD)
• History of vitreous hemorrhage
• Previous vitreoretinal surgery
• Previous intravitreal injections (IVT)
• Retinal diseases affecting vitreoretinal interface assessment
• Pathologic high myopia
• History of ocular trauma or uveitis

Sponsors & Collaborators

• University of Trieste: lead

Study Sites (1)

Centre Hospitalier Intercommunal de Créteil

Créteil, Paris, 94000, France

RECRUITING

MeSH Terms

Conditions

Vitreous Detachment; Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 14, 2026
• Study Start: July 30, 2026
• Primary Completion: September 20, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

FR (1)