Clinical trial NCT06826573: Analysis of Risk Factors for High Intraocular Pressure and Retinal Detachment Recurrence After Vitrectomy with Silicone Oil Tamponade in Retinal Detachment Patients
Official title: Analysis of Risk Factors for High Intraocular Pressure and Retinal Detachment Recurrence After Vitrectomy with Silicone Oil Tamponade in Retinal Detachment Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rhegmatogenous Retinal Detachment
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.


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.

Primary outcomes:
measure: Intraocular pressure
timeFrame: 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
measure: the retinal recovery status
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References: