GlaucomaNCT06524661
Anterior Segment Changes After Pars Plana Vitrectomy With SO Using AS-OCT
An observational study of Glaucoma, run by Minia University at 1 site in Egypt.
Trial summary
To evaluate changes in ACA induced by pars plana vitrectomy with SO 1000cs injection in vitreo-retinal surgery in phakic eyes using AS-OCT and changes in the IOP preoperatively, post-operatively and post-silicone oil evacuation. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- AS-OCT after vitrectomy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2023to 15 Apr 2024
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are phakic with rhegmatogenous retinal detachment
Who may be able to join
- • Patients with rhegmatogenous retinal detachment who are going to undergo vitreoretinal surgery with silicone oil 1000cs injection as tamponade
Who cannot join
- Patients with history of intraocular surgery, laser therapy or intravitreal injection.
- Patients with significant corneal opacity.
- Patients with ocular diseases as retinal vein occlusion, uveitis and proliferative diabetic retinopathy.
- Patients with preexisting glaucoma or family history of glaucoma.
- Patients with nystagmus.
- Patient with tractional retinal detachment, exudative retinal detachment or intraocular foreign body.
- Patients with anterior chamber abnormalities including posterior synechia, peripheral anterior synechia, hyphaema and iris abnormalities.
- Patients with severe proliferative vitreoretinopathy grade C or more.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterior Segment Changes After Pars Plana Vitrectomy With Silicone Oil Tamponade And After Silicone Oil Evacuation Using AS-OCT.
To evaluate changes in ACA induced by pars plana vitrectomy with SO 1000cs injection in vitreo-retinal surgery in phakic eyes using AS-OCT and changes in the IOP preoperatively, post-operatively and post-silicone oil evacuation.
Read the detailed description
Abstract Introduction Ocular hypertension and secondary glaucoma are relatively common and serious complications in silicone filled eyes which may end in blindness. Reports have described the percentage of incidence to be within 3 - 30 % of silicon filled eye which are complicated with secondary glaucoma. [1] Aim of study Evaluation of changes in anterior chamber angle and intra-ocular pressure (IOP) in patients with rhegmatogenous retinal detachment (RRD) who underwent pars plana vitrectomy (PPV) with silicone oil (SO) 1000cs tamponade and after silicone oil evacuation.
Population The study was a prospective interventional study. The study included 30 eyes from 30 patients with rhegmatogenous retinal detachment (RRD) who are going to undergo PPV with SO injection. The study was conducted at Ophthalmology department, Minia University Hospital in Egypt between April 2023 and April 2024.
- Conditions
- Glaucoma
- Being tested
- AS-OCT after vitrectomy
- Keywords
- ASOCT, Glaucoma, Silicone, vitrectomy, angle
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS-OCT after vitrectomyDevice
Also called vitrectomy, silicone oil 1000cs, silicone oil evacuation
AS-OCT is a light based imaging technique of the anterior segment of the eye in this study it is used to measure the anterior chamber angle changes after pars plana vitrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with RRD who underwent pars plana vitrectomy with | AS-oct measuring the anterior chamber angle and corneal changes after pars plana vitrectomy with silicone oil 1000cs injection Receives: Device: AS-OCT after vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessement of the changes in anterior chamber angle after vitrectomy with silicone oil injection
Evaluation of changes in the anterior chamber angle parameters after vitrectomy with silicone oil 1000cs injection.
The measures include AOD 500, TISA 500, ACA and CCT The measuring tool is AS-OCT (anterior segment optical coherent topography)
Measured: postoperative evaluation for 3 months duration (5 visits pre-ppv then one week, one month, three months )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start15 Apr 2023
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohab Mohamed Khairy Talaat, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524661
- Sponsor's protocol ID
- AS-OCT after PPV with SO
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Calik B, Ozturk M, Serdarogullari H, Elcioglu M. Evaluation of anterior segment parameters using pentacam in silicone oil-injected patients after pars plana vitrectomy. Indian J Ophthalmol. 2013 Nov;61(11):621-5. doi: 10.4103/0301-4738.123137.
PubMed 24343592
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Segment Changes After Pars Plana Vitrectomy With Silicone Oil Tamponade And After Silicone Oil Evacuation Using AS-OCT.
- ClinicalTrials.gov ID
- NCT06524661
- Acronym / sponsor ID
- AS-OCT after PPV with SO
- Conditions
- Glaucoma
- Keywords
- ASOCT, Glaucoma, Silicone, vitrectomy, angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 29 Jul 2024 (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.
To evaluate changes in ACA induced by pars plana vitrectomy with SO 1000cs injection in vitreo-retinal surgery in phakic eyes using AS-OCT and changes in the IOP preoperatively, post-operatively and post-silicone oil evacuation.
Detailed description
Abstract Introduction Ocular hypertension and secondary glaucoma are relatively common and serious complications in silicone filled eyes which may end in blindness. Reports have described the percentage of incidence to be within 3 - 30 % of silicon filled eye which are complicated with secondary glaucoma. [1] Aim of study Evaluation of changes in anterior chamber angle and intra-ocular pressure (IOP) in patients with rhegmatogenous retinal detachment (RRD) who underwent pars plana vitrectomy (PPV) with silicone oil (SO) 1000cs tamponade and after silicone oil evacuation.
Population The study was a prospective interventional study. The study included 30 eyes from 30 patients with rhegmatogenous retinal detachment (RRD) who are going to undergo PPV with SO injection. The study was conducted at Ophthalmology department, Minia University Hospital in Egypt between April 2023 and April 2024.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with RRD who underwent pars plana vitrectomy with | – | Device: AS-OCT after vitrectomyAS-oct measuring the anterior chamber angle and corneal changes after pars plana vitrectomy with silicone oil 1000cs injection |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are phakic with rhegmatogenous retinal detachment
Key inclusion criteria (1 listed)
- • Patients with rhegmatogenous retinal detachment who are going to undergo vitreoretinal surgery with silicone oil 1000cs injection as tamponade
Key exclusion criteria (8 listed)
- Patients with history of intraocular surgery, laser therapy or intravitreal injection.
- Patients with significant corneal opacity.
- Patients with ocular diseases as retinal vein occlusion, uveitis and proliferative diabetic retinopathy.
- Patients with preexisting glaucoma or family history of glaucoma.
- Patients with nystagmus.
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 |
|---|---|---|
| AS-OCT after vitrectomyAlso: vitrectomy, silicone oil 1000cs, silicone oil evacuationAS-OCT is a light based imaging technique of the anterior segment of the eye in this study it is used to measure the anterior chamber angle changes after pars plana vitrectomy. | Device | Patients with RRD who underwent pars plana vitrectomy with |
Primary outcome
Assessement of the changes in anterior chamber angle after vitrectomy with silicone oil injection
Time frame: postoperative evaluation for 3 months duration (5 visits pre-ppv then one week, one month, three months )
Evaluation of changes in the anterior chamber angle parameters after vitrectomy with silicone oil 1000cs injection. The measures include AOD 500, TISA 500, ACA and CCT The measuring tool is AS-OCT (anterior segment optical coherent topography)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Background: PubMed 24343592Calik B, Ozturk M, Serdarogullari H, Elcioglu M. Evaluation of anterior segment parameters using pentacam in silicone oil-injected patients after pars plana vitrectomy. Indian J Ophthalmol. 2013 Nov;61(11):621-5. doi: 10.4103/0301-4738.123137.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Glaucoma, run by Minia University at 1 site in Egypt.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 29 Jul 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessement of the changes in anterior chamber angle after vitrectomy with silicone oil injection (time frame: postoperative evaluation for 3 months duration (5 visits pre-ppv then one week, one month, three months )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06524661, which also lists 1 linked publication.
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 29 Jul 2024.