Rhegmatogenous Retinal DetachmentNCT06826573
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 of Rhegmatogenous Retinal Detachment, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- What is being tested?
- Intraocular pressure and retinal recovery status
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042
Hui Peng, 13072369950, pengh9@sina.com
About this study
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
- Being tested
- Intraocular pressure, retinal recovery status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular pressureDiagnostic 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.
retinal recovery statusDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Subjects who exhibit elevated intraocular pressure during the follow-up period. Receives: Diagnostic Test: Intraocular pressure | |
| group 2 | Subjects with normal intraocular pressure during the follow-up period. Receives: Diagnostic Test: Intraocular pressure | |
| group 3 | Subjects who experience retinal detachment recurrence during the follow-up period. Receives: Diagnostic Test: retinal recovery status | |
| group 4 | Subjects who do not experience retinal detachment recurrence during the follow-up period. Receives: Diagnostic Test: retinal recovery status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Sep 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Peng, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826573
- Sponsor's protocol ID
- 2024-130-01
- Status last verified
- Sep 2024
- First submitted
- 10 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Risk Factors for High Intraocular Pressure and Retinal Detachment Recurrence After Vitrectomy with Silicone Oil Tamponade in Retinal Detachment Patients
- ClinicalTrials.gov ID
- NCT06826573
- Acronym / sponsor ID
- 2024-130-01
- Conditions
- Rhegmatogenous Retinal Detachment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Diagnostic Test: Intraocular pressureSubjects who exhibit elevated intraocular pressure during the follow-up period. |
| group 2 | – | Diagnostic Test: Intraocular pressureSubjects with normal intraocular pressure during the follow-up period. |
| group 3 | – | Diagnostic Test: retinal recovery statusSubjects who experience retinal detachment recurrence during the follow-up period. |
| group 4 | – | Diagnostic Test: retinal recovery statusSubjects who do not experience retinal detachment recurrence during the follow-up period. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular pressureIntraocular 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 | group 1, group 2 |
| retinal recovery statusMeasure and record the retinal recovery status 1 day, 1 week, 1 month, 3 months, 6 months after surgery and before silicone oil removal. | Diagnostic test | group 3, group 4 |
Primary outcome
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
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 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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhegmatogenous Retinal Detachment, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Peng (13072369950, pengh9@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.