Retinal DetachmentNCT04712786
Refractive Changes Following Vitrectomy
An observational study of Retinal Detachment and Refractive Errors, run by Bursa Retina Eye Hospital at 1 site in Turkey (Türkiye).
Trial summary
We aimed o compare the refractive changes associated with pars plana vitrectomy with or without intraocular gas tamponade in pseudophakic eyes. This retrospective study included pseudophakic patients with Nd:YAG laser posterior capsulotomy who underwent 23G PPV between February 2015 and March 2019. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment, Refractive Errors, Vitreous Hemorrhage
- What is being tested?
- pars plana vitrectomy
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 27 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pseudophakic patients treated with neodymium:yttrium-aluminum-garnet Nd: YAG laser and subsequently underwent 23 gauge pars plana vitrectomy for vitreous hemorrhage, epiretinal membrane, or rhegmatogenous retinal detachment.
Who may be able to join
- Patients aged ≥ 18 years
- Pseudophakic patients who underwent pars plana vitrectomy
Who cannot join
- Patients aged 18 years >
- Patients with a spherical refractive error > ±6 D
- Patients with a cylindrical refractive error > ±3 D
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Refractive Changes in Pseudophakic Eyes Following Vitrectomy With or Without Gas Tamponade
We aimed o compare the refractive changes associated with pars plana vitrectomy with or without intraocular gas tamponade in pseudophakic eyes. This retrospective study included pseudophakic patients with Nd:YAG laser posterior capsulotomy who underwent 23G PPV between February 2015 and March 2019. Group 1 consisted of patients with regmatogenous RD who underwent PPV and 12% perflouropropane (C3F8) gas tamponade whereas Group 2 consisted of patients who underwent PPV for epiretinal membrane or vitreous hemorrhage (VH). No tamponade was used in Group 2. Minimum follow-up was 12 months.
Read the detailed description
This research was reviewed by an independent ethical review board and conforms with the principles and applicable guidelines for the protection of human subjects in biomedical research. This was a retrospective, comparative case series including pseudophakic patients who underwent PPV. Group 1 consisted of patients with pseudophakic RRD who underwent PPV and 12% perflouropropane (C3F8) gas tamponade whereas Group 2 consisted of patients with ERM or VH who underwent PPV without any tamponade between February 2015 and March 2019 at Bursa Retina Eye Hospital. Informed consent was obtained from all the participants. The study was in line with the ethical standarts of the Helsinki Declaration
Patient eligibility Patients who underwent uncomplicated cataract surgery with phacoemulsification and in-the-bag IOL implantation and subsequent neodymium:yttrium-aluminum-garnet (Nd:YAG) laser due to capsular opacification were included. Preoperative refractive data obtained after Nd:YAG laser and six months prior to vitrectomy surgery. Postoperative refractive data was obtained at 12 months after vitrectomy. Eyes with a preoperative spherical refractive error > ±6 D or cylindrical refractive error > ±3 D were excluded. Also eyes with corneal disorders were excluded.
Ocular parameters
All patients underwent complete ophtalmic examination including best corrected visual acuity (BCVA) in the logMAR scale, slit-lamp examination, intraocular pressure (IOP) assessment, fundus examination and autokeratorefractometry (auto kerato-refractometer KR-8800 from Topcon, Tokyo, Japan) at preoperative and postoperative month-12. Induced astigmatism values were calculated through vector analysis.
Surgical procedures
All surgeries were performed by the same surgeon (S.Y.). Retrobulbar block anesthesia (a mixture of 2 ml of lidocaine hydrochloride 2% and 2 ml of bupivacaine hydrochloride 0.5%) was used. Three port 23-gauge (G) transconjunctival PPV was performed using the vitrectomy system DORC (Dutch Ophthalmic Research Center, Zuidland, Netherlands) and Zeiss microscope with EIBOS 2 (Haag Streit, Mason, OH, USA) attachment for non-contact fundus viewing.
In group 1, all patients underwent a near-complete vitrectomy including base shaving, laser endo-photocoagulation and C3F8 gas tamponade. In group 2, patients with ERM received a limited vitrectomy including; core vitrectomy, induction of a posterior vitreous detachment if not present and peeling of the ERM and inner limiting membrane (ILM). Peripheral retina was examined with indentation to identify any retinal breaks. Neither laser endo-photocoagulation, nor gas tamponade and vitreous base shaving was performed. For patients with VH patients, a near-complete vitrectomy, including base shaving, laser endo-photocoagulation was performed except for gas tamponade. In both groups, the sclera is sutured with 8-0 polyglactin suture (Vicryl) in case of wound leakage.
- Being tested
- pars plana vitrectomy
- Keywords
- Myopic shift, Gas tamponade, Pars plana vitrectomy
- Medical subject headings
- Retinal Detachment, Refractive Errors, Vitreous Hemorrhage, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pars plana vitrectomyOther
23 gauge pars plana vitrectomy was performed for retinal detachment, vitreous hemorrhage or epiretinal membrane
| Study group | Role | What they receive |
|---|---|---|
| Group | 27 patients, Group 1 consisted of patients with pseudophakic rhegmatogoneous retinal detachment who underwent pars plana vitrectomy and 12% perflouropropane (C3F8) gas tamponade and 20 patients Group 2 consisted of patients with epiretinal membrane or vitreous hemorrhage who underwent PPV without any tamponade Receives: Other: pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of spherical and cylindrical refractive changes
Changes in spherical and cylindrical refractive error 12 months after pars plana vitrectomy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Dec 2020
- Primary completion25 Dec 2020
- Study completion27 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Retina Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sami yilmaz, Bursa Retina Eye Hospital
- Investigators
- Sami Yılmaz, MD, Principal investigator, Bursa Retina Eye HospitalRemzi Avcı, Professor, Study director, Bursa Retina Eye HospitalAysegul Mavi Yıldız, MD, Principal investigator, Bursa Retina Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712786
- Sponsor's protocol ID
- BursaRetinaEyeH
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hamoudi H, Kofod M, La Cour M. Refractive change after vitrectomy for epiretinal membrane in pseudophakic eyes. Acta Ophthalmol. 2013 Aug;91(5):434-6. doi: 10.1111/j.1755-3768.2012.02574.x. Epub 2012 Sep 23.
PubMed 22998208Byrne S, Ng J, Hildreth A, Danjoux JP, Steel DH. Refractive change following pseudophakic vitrectomy. BMC Ophthalmol. 2008 Oct 13;8:19. doi: 10.1186/1471-2415-8-19.
PubMed 18851731
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive Changes in Pseudophakic Eyes Following Vitrectomy With or Without Gas Tamponade
- ClinicalTrials.gov ID
- NCT04712786
- Acronym / sponsor ID
- BursaRetinaEyeH
- Keywords
- Myopic shift, Gas tamponade, Pars plana vitrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Bursa Retina Eye HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 27 Dec 2020 (actual)
- First posted
- 15 Jan 2021 (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.
We aimed o compare the refractive changes associated with pars plana vitrectomy with or without intraocular gas tamponade in pseudophakic eyes. This retrospective study included pseudophakic patients with Nd:YAG laser posterior capsulotomy who underwent 23G PPV between February 2015 and March 2019. Group 1 consisted of patients with regmatogenous RD who underwent PPV and 12% perflouropropane (C3F8) gas tamponade whereas Group 2 consisted of patients who underwent PPV for epiretinal membrane or vitreous hemorrhage (VH). No tamponade was used in Group 2. Minimum follow-up was 12 months.
Detailed description
This research was reviewed by an independent ethical review board and conforms with the principles and applicable guidelines for the protection of human subjects in biomedical research. This was a retrospective, comparative case series including pseudophakic patients who underwent PPV. Group 1 consisted of patients with pseudophakic RRD who underwent PPV and 12% perflouropropane (C3F8) gas tamponade whereas Group 2 consisted of patients with ERM or VH who underwent PPV without any tamponade between February 2015 and March 2019 at Bursa Retina Eye Hospital. Informed consent was obtained from all the participants. The study was in line with the ethical standarts of the Helsinki Declaration
Patient eligibility Patients who underwent uncomplicated cataract surgery with phacoemulsification and in-the-bag IOL implantation and subsequent neodymium:yttrium-aluminum-garnet (Nd:YAG) laser due to capsular opacification were included. Preoperative refractive data obtained after Nd:YAG laser and six months prior to vitrectomy surgery. Postoperative refractive data was obtained at 12 months after vitrectomy. Eyes with a preoperative spherical refractive error > ±6 D or cylindrical refractive error > ±3 D were excluded. Also eyes with corneal disorders were excluded.
Ocular parameters
All patients underwent complete ophtalmic examination including best corrected visual acuity (BCVA) in the logMAR scale, slit-lamp examination, intraocular pressure (IOP) assessment, fundus examination and autokeratorefractometry (auto kerato-refractometer KR-8800 from Topcon, Tokyo, Japan) at preoperative and postoperative month-12. Induced astigmatism values were calculated through vector analysis.
Surgical procedures
All surgeries were performed by the same surgeon (S.Y.). Retrobulbar block anesthesia (a mixture of 2 ml of lidocaine hydrochloride 2% and 2 ml of bupivacaine hydrochloride 0.5%) was used. Three port 23-gauge (G) transconjunctival PPV was performed using the vitrectomy system DORC (Dutch Ophthalmic Research Center, Zuidland, Netherlands) and Zeiss microscope with EIBOS 2 (Haag Streit, Mason, OH, USA) attachment for non-contact fundus viewing.
In group 1, all patients underwent a near-complete vitrectomy including base shaving, laser endo-photocoagulation and C3F8 gas tamponade. In group 2, patients with ERM received a limited vitrectomy including; core vitrectomy, induction of a posterior vitreous detachment if not present and peeling of the ERM and inner limiting membrane (ILM). Peripheral retina was examined with indentation to identify any retinal breaks. Neither laser endo-photocoagulation, nor gas tamponade and vitreous base shaving was performed. For patients with VH patients, a near-complete vitrectomy, including base shaving, laser endo-photocoagulation was performed except for gas tamponade. In both groups, the sclera is sutured with 8-0 polyglactin suture (Vicryl) in case of wound leakage.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | – | Other: pars plana vitrectomy27 patients, Group 1 consisted of patients with pseudophakic rhegmatogoneous retinal detachment who underwent pars plana vitrectomy and 12% perflouropropane (C3F8) gas tamponade and 20 patients Group 2 consisted of patients with epiretinal membrane or vitreous hemorrhage who underwent PPV without any tamponade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pseudophakic patients treated with neodymium:yttrium-aluminum-garnet Nd: YAG laser and subsequently underwent 23 gauge pars plana vitrectomy for vitreous hemorrhage, epiretinal membrane, or rhegmatogenous retinal detachment.
Key inclusion criteria (2 listed)
- Patients aged ≥ 18 years
- Pseudophakic patients who underwent pars plana vitrectomy
Key exclusion criteria (3 listed)
- Patients aged 18 years >
- Patients with a spherical refractive error > ±6 D
- Patients with a cylindrical refractive error > ±3 D
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 |
|---|---|---|
| pars plana vitrectomy23 gauge pars plana vitrectomy was performed for retinal detachment, vitreous hemorrhage or epiretinal membrane | Other | Group |
Primary outcome
The rate of spherical and cylindrical refractive changes
Time frame: 12 months
Changes in spherical and cylindrical refractive error 12 months after pars plana vitrectomy
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 15 Jan 2021.
- Background: PubMed 22998208Hamoudi H, Kofod M, La Cour M. Refractive change after vitrectomy for epiretinal membrane in pseudophakic eyes. Acta Ophthalmol. 2013 Aug;91(5):434-6. doi: 10.1111/j.1755-3768.2012.02574.x. Epub 2012 Sep 23.
- Results publication: PubMed 18851731Byrne S, Ng J, Hildreth A, Danjoux JP, Steel DH. Refractive change following pseudophakic vitrectomy. BMC Ophthalmol. 2008 Oct 13;8:19. doi: 10.1186/1471-2415-8-19.
- Individual participant dataSharing planned: Undecided
Related trials for Retinal Detachment
Recruiting
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Stickler Syndrome Type 1, Stickler Syndrome Type 2
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
RecruitingPhase 1/2
Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment
Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy
Not yet recruitingPhase 1
The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy
Proliferative Vitreoretinopathy, Proliferative Vitreo-Retinopathy
Active, not recruiting
Ocular Hypotony and Refractive Predictability in RRD Surgery
Rhegmatogenous Retinal Detachment, Hypotony Ocular
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.
Sami Yılmaz, MD principal investigator
Bursa Retina Eye Hospital
Remzi Avcı, Professor study director
Bursa Retina Eye Hospital
Aysegul Mavi Yıldız, MD principal investigator
Bursa Retina Eye Hospital
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 Retinal Detachment and Refractive Errors, run by Bursa Retina Eye Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 15 Jan 2021. 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 Turkey (Türkiye). 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?
The rate of spherical and cylindrical refractive changes (time frame: 12 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 NCT04712786, which also lists 2 linked publications.
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 15 Jan 2021; AzTrials last refreshed its copy on 27 Oct 2026.