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RecruitingNCT06826573Updated Feb 14, 2025

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

An observational study in Rhegmatogenous Retinal Detachment, sponsored by First Affiliated Hospital of Chongqing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-02-14.

Sponsored by First Affiliated Hospital of Chongqing Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
65
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Rhegmatogenous Retinal Detachment

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03

In context

Retinal Detachment

199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.

This study's planned enrollment of 65 is close to the median of 60 across 58 observational studies indexed under Retinal Detachment.

Browse Retinal Detachment studies →

Lead sponsor

First Affiliated Hospital of Chongqing Medical University is the lead sponsor of 95 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study includes patients with rhegmatogenous retinal detachment who visited the ophthalmology clinic of the First Affiliated Hospital of Chongqing Medical University between September 1, 2024, and December 31, 2025.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

      1. Intraocular pressure of both eyes is less than 21 mmHg before surgery, and having no personal or family history of glaucoma.
      1. Cup - to - disc ratio (C/D) in fundus examination is less than 0.5 for both eyes.
      1. Those who understand the purpose of this study, sign the " Form" and have a high degree of compliance.

Exclusion criteria

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.
  1. 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
65 participants (estimated)
Patient registry
No

Groups and cohorts

  • group 1

    Subjects who exhibit elevated intraocular pressure during the follow-up period.

    Diagnostic Test: Intraocular pressure

  • group 2

    Subjects with normal intraocular pressure during the follow-up period.

    Diagnostic Test: Intraocular pressure

  • group 3

    Subjects who experience retinal detachment recurrence during the follow-up period.

    Diagnostic Test: retinal recovery status

  • group 4

    Subjects who do not experience retinal detachment recurrence during the follow-up period.

    Diagnostic Test: retinal recovery status

Interventions

  • Diagnostic testIntraocular 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 testretinal 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.

06

What researchers measure

Primary outcomes

  1. Intraocular pressure

    If the intraocular pressure is greater than 21 mmHg at any time during the follow - up period, it is considered as an increase in 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

  2. the retinal recovery status

    Measure and record the retinal status 1 day, 1 week, 1 month, 3 months, 6 months after surgery and before silicone - oil removal. If retinal detachment occurs again, it is regarded as the recurrence of retinal detachment.

    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.

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No — Our institution has established strict privacy - protection policies. Our organization adheres to high - level data - security regulations. These regulations prohibit the sharing of any patient - related data, including individual patient data, to prevent potential data breaches and ensure the confidentiality of patients' personal and medical information.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06826573
Lead sponsor
First Affiliated Hospital of Chongqing Medical University
Responsible party
Hui Peng (PH.D, First Affiliated Hospital of Chongqing Medical University) — Principal investigator
First posted
Feb 14, 2025
Start date
Sep 1, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Feb 14, 2025

Study contacts

Hui Peng
Contact
pengh9@sina.com
13072369950

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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