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Recruiting NCT06826573

Analysis of Risk Factors for High Intraocular Pressure and Retinal Detachment Recurrence After Vitrectomy with Silicone Oil Tamponade in Retinal Detachment Patients

Observational Rhegmatogenous Retinal Detachment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intraocular pressure, retinal recovery status.
Who it may be relevant to
Registry conditions: Rhegmatogenous Retinal Detachment. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study is a retrospective study. Patients who visited the ophthalmology clinic of the First Affiliated Hospital of Chongqing Medical University between September 1, 2024, and December 31, 2025, will be screened according to the inclusion and exclusion criteria mentioned below. After obtaining informed consent, clinical data of the subjects will be collected. The surgical procedure will involve "vitrectomy + retinal laser photocoagulation + retinal reattachment + silicone oil tamponade (+ cataract extraction + intraocular lens implantation)." Observation indicators will be recorded at various time points postoperatively: 1 day, 1 week, 1 month, 3 months, 6 months, and before silicone oil removal. Any emergent events occurring during the trial will be treated accordingly. Finally, data will be statistically analyzed to identify risk factors for high intraocular pressure and retinal detachment recurrence in patients with rhegmatogenous retinal detachment.

Interventions

  • Diagnostic test Intraocular pressure
    Intraocular pressure will be measured and recorded at 1 day, 1 week, 1 month, 3 months, 6 months postoperatively, and before silicone oil removal.
  • Diagnostic test retinal recovery status
    Measure and record the retinal recovery status 1 day, 1 week, 1 month, 3 months, 6 months after surgery and before silicone oil removal.

Primary outcome measures

  • Intraocular pressure [Time frame: The study will be conducted from September 1, 2024, to December 31, 2025. Key follow-up time points include 1 day, 1 week, 1 month, 3 months, 6 months postoperatively, and before silicone oil removal]
  • the retinal recovery status [Time frame: The study will be conducted from September 1, 2024, to December 31, 2025. Key follow-up time points include 1 day, 1 week, 1 month, 3 months, 6 months postoperatively, and before silicone oil removal.]

Eligibility criteria

Inclusion criteria

  • 1\. Diagnosed with "rhegmatogenous retinal detachment". 2. Aged over 18 years old, with normal mental and psychological status, regardless of gender.

3\. Intraocular pressure of both eyes is less than 21 mmHg before surgery, and having no personal or family history of glaucoma.

4\. Cup - to - disc ratio (C/D) in fundus examination is less than 0.5 for both eyes.

5\. Those who understand the purpose of this study, sign the "Informed Consent Form" and have a high degree of compliance.

Exclusion criteria

\- 1. Those with high intraocular pressure before surgery and suffering from ophthalmic diseases such as glaucoma; 3. Those with acute or chronic systemic infections and hematological diseases; 4. Those with a history of mental and psychological diseases; 5. Those with incomplete survey data or unable to cooperate with this research. 5. Those with traumatic rhegmatogenous retinal detachment; 6. Those with active ocular infectious lesions in either eye; 7. Those with severe refractive media opacity (such as corneal nebula, corneal leukoma) in the target eye, which affects imaging examinations during postoperative follow - up.

8\. Those with a history of congenital structural abnormalities in the target eye; 9. Those who have undergone vitrectomy for other vitreoretinal diseases in the target eye before screening; 10. Those whom the researchers consider unfit to participate in this clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing

Identifiers

NCT: NCT06826573 · 2024-130-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗