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

NCT06826573 | Recruiting

• 1 other identifier: 2024-130-01
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhegmatogenous Retinal Detachment

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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.

  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.

Study Arms (4)

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

Intraocular pressure DIAGNOSTIC_TEST

Intraocular pressure will be measured and recorded at 1 day, 1 week, 1 month, 3 months, 6 months postoperatively, and before silicone oil removal.

group 1; group 2

retinal recovery status DIAGNOSTIC_TEST

Measure and record the retinal recovery status 1 day, 1 week, 1 month, 3 months, 6 months after surgery and before silicone oil removal.

group 3; group 4

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. Diagnosed with "rhegmatogenous retinal detachment". 2. Aged over 18 years old, with normal mental and psychological status, regardless of gender.
• \. Intraocular pressure of both eyes is less than 21 mmHg before surgery, and having no personal or family history of glaucoma.
• \. Cup - to - disc ratio (C/D) in fundus examination is less than 0.5 for both eyes.
• \. Those who understand the purpose of this study, sign the "Informed Consent Form" and have a high degree of compliance.

You may not qualify if:

• \- 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.
• \. 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.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Interventions

Intraocular Pressure

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Central Study Contacts

Hui Peng

CONTACT

13072369950; pengh9@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PH.D

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: September 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 14, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)