GlaucomaNCT05790408
Anterior-segment OCT (AS-OCT) and Intraoperative OCT (iOCT) for Trans- Conjunctival Needle Revision (TCNR)
A study testing Digital microscope integrated with intraoperative OCT (Zeiss Artevo 800, Carl Zeiss Meditec AG) and Spectralis Anterior-segment OCT (AS-OCT) (Heidelberg Engineering) in people with Glaucoma and Glaucoma Following Surgery, run by Northwestern University at 1 site in United States.
Trial summary
Trabeculectomy is a very important and commonly performed glaucoma operation. It allows fluid from inside the eye to exit into a space called a bleb located on the surface of the eye under the upper eyelid. The formation of excessive scar tissue after surgery may cause the operation to work less well or stop working. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Glaucoma Following Surgery
- What is being tested?
- Digital microscope integrated with intraoperative OCT (Zeiss Artevo 800, Carl Zeiss Meditec AG) and Spectralis Anterior-segment OCT (AS-OCT) (Heidelberg Engineering)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2020to 12 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Briefly, the diagnosis of glaucoma is based on the presence of 2 or more of the following findings: 1) glaucomatous optic disc damage, defined as the presence of optic disc excavation, diffuse or focal neuroretinal rim thinning or notching, localized or generalized retinal nerve fiber layer (RNFL) thinning; 2) visual field defects consistent with glaucoma; and 3) IOP ≥ 22 mmHg.
- Patients with glaucoma who have been advised to undergo TCNR of a failed trabeculectomy bleb by a glaucoma specialist at Northwestern Medicine
- History of failed trabeculectomy (based on clinical features of the trabeculectomy bleb and elevated intraocular pressure)
- Patients can have history of other glaucoma surgery or cataract surgery
- The diagnosis of glaucoma is based on the presence of 2 or more of the following findings: 1) glaucomatous optic disc damage, defined as the presence of optic disc excavation, diffuse or focal neuroretinal rim thinning or notching, localized or generalized RNFL thinning; 2) visual field defects consistent with glaucoma; and 3) IOP ≥ 22 mmHg.
Who cannot join
- Age younger than 18 years;
- Secondary causes of glaucoma (e.g., iridocyclitis, trauma);
- Any evidence of corneal or conjunctival pathology adjacent to filtration bleb that could influence AS-OCT image
- Patients who did not undergo surgery or have adequate follow up
- Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and vulnerable populations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterior-segment OCT (AS-OCT) and Intraoperative OCT (iOCT) for Trans- Conjunctival Needle Revision (TCNR) of Trabeculectomy Bleb
Trabeculectomy is a very important and commonly performed glaucoma operation. It allows fluid from inside the eye to exit into a space called a bleb located on the surface of the eye under the upper eyelid. The formation of excessive scar tissue after surgery may cause the operation to work less well or stop working. This results in an increase in eye pressure. The use of a needle to cut the scar tissue is a commonly used procedure. This surgery is called trans-conjunctival needle revision (TCNR) of trabeculectomy bleb.
The study aims to determine if advanced optical imaging called Optical Coherence Tomography (OCT) of the scar tissue both in the office prior to surgery and during surgery in the operating room improves the success rate of the revision surgery. These devices are FDA approved and have been used extensively in ophthalmology and ocular surgery.
Ophthalmologists already used these imaging devices for this purpose as part of the standard medical care of some patients. The purpose of this study is to prospectively gather information about its use in a systematic way. Furthermore, investigators want to determine if imaging improves outcomes compared to historical controls (patients who underwent the same surgery in the past without imaging). The potential benefit of this research is that it may provide knowledge that will be of benefit to future patients with glaucoma who are undergoing this procedure.
Read the detailed description
Trabeculectomy is one of the most commonly performed glaucoma procedures performed to control IOP with approximately 18,000 operations performed in US Medicare beneficiaries alone in 2012. One complication of trabeculectomy surgery is the formation of subconjunctival and episcleral fibrosis, which occurs as part of the wound healing process and can result in fibrosis of the filtering bleb and failure. Transconjunctival needle revision (TCNR) aims to lyse subconjunctival adhesions and reestablish adequate aqueous humor flow from the anterior chamber to the subconjunctival space. One study reported 17% of trabeculectomies require bleb-needling revision. During TCNR the surgeon is able to visualize the trajectory of the needle or blade under the conjunctiva; however, detection of the fibrotic tissue and determination as to whether that tissue has been adequately lysed is difficult, limiting the success rate of the procedure.
Anterior segment optical coherence tomography (AS-OCT) allows for detailed assessment of the internal morphology of the bleb. Studies have utilized AS-OCT to assess morphological features of the bleb and correlate it with surgical success. A small case series reported the utility of AS-OCT for pre-operative planning for bleb revision, in particular, identifying safe access sites and minimizing conjunctival dissection.
More recently, real time OCT integrated with operative microscope has become available. Intraoperative OCT (iOCT) has been utilized extensively in retinal surgery and corneal surgery. Dada et al., described performing iOCT-guided TCNR in 2 patients with failed trabeculectomy blebs without intraoperative or postoperative complications. Investigators reported they were able to obtain a detailed view of the bleb wall and assess the depth and location of the needle, which permitted better lysis of adhesions. A pilot study by Kumar et al., reported one case of TCNR in which iOCT was used to demonstrate the extent of adhesions and loculations inside the bleb at the beginning of the procedure, and the lysis of these adhesions and formation of large single hyporeflective cavity inside the bleb at the end of the procedure. These small case studies suggest a role of iOCT imaging for TCNR, however, further research is needed to assess its feasibility and utility for routine use.
The aim of the research is to assess the surgical success, feasibility and utility of pre-operative Anterior Segment Optical Coherence Tomography (AS-OCT) and intraoperative Optical Coherence Tomography (iOCT) in trans-conjunctival needle revision (TCNR) of trabeculectomy bleb. Furthermore, investigators want to assess whether AS-OCT can be used to identify characteristics of trabeculectomy blebs that are associated with successful surgical outcomes.
To undergo this study, investigators will conduct a prospective study of patients who consent to AS-OCT and iOCT revision of TCNR. Investigators will compare the outcomes of these patients with retrospectively identified, historical controls (i.e. patients who underwent TCNR by the same surgeon without AS-OCT or iOCT assistance).
investigators hypothesize that information gained from pre-operative AS-OCT and intraoperative OCT will aid with intraoperative decision-making for TCNR of trabeculectomy bleb and will thereby improve surgical outcomes. Investigators also hypothesize that preoperative AS-OCT can be used to identify features of trabeculectomy bleb that can predict success with iOCT-assisted TCNR. More specifically, investigators hypothesize that filtering blebs with more extensive scarring as seen on pre-operative AS-OCT will benefit from iOCT.
- Conditions
- Glaucoma, Glaucoma Following Surgery
- Being tested
- Digital microscope integrated with intraoperative OCT (Zeiss Artevo 800, Carl Zeiss Meditec AG), Spectralis Anterior-segment OCT (AS-OCT) (Heidelberg Engineering)
- Keywords
- optical coherence tomography
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital microscope integrated with intraoperative OCT (Zeiss Artevo 800, Carl Zeiss Meditec AG)Device
The Zeiss Artevo digital microscope integrated with iOCT (Zeiss Artevo 800, Carl Zeiss Meditec AG) is a commercially available, FDA approved device that can be utilized to visualize and evaluate the morphology of the trabeculectomy bleb during transconjunctival needle revision of trabeculectomy bleb.
Spectralis Anterior-segment OCT (AS-OCT) (Heidelberg Engineering)Device
The Spectralis Anterior-segment OCT (AS-OCT) is a commercially available, FDA approved device that can be utilized to visualize and evaluate the morphology of the trabeculectomy bleb in the office.
| Study group | Role | What they receive |
|---|---|---|
| AS-OCT and iOCT | Other | This prospective study will include approximately 25 patients with open-angle glaucoma who will undergo TCNR of trabeculectomy bleb by a glaucoma specialist at Northwestern Medicine. These patients will have a history of glaucoma and failed trabeculectomy bleb (as evidenced by clinical features and elevated IOP). During routine clinic visit, the patient will undergo lit lamp grading of bleb by Indiana Bleb Appearance Grading Score (IBAGS). Subjects who agree to participate and provide written informed consent will undergo AS-OCT imaging (Spectralis OCT, Heidelberg) of the bleb. During their operation, the Zeiss Artevo digital microscope integrated with iOCT (Zeiss Artevo 800, Carl Zeiss Meditec AG), a commercially available device will be utilized to visualize and evaluate the morphology of the trabeculectomy bleb at the start and conclusion of the case. Receives: Device: Digital microscope integrated with intraoperative OCT (Zeiss Artevo 800, Carl Zeiss Meditec AG); Device: Spectralis Anterior-segment OCT (AS-OCT) (Heidelberg Engineering) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Success
Surgical success as defined as a 20% reduction in unmedicated IOP below the pre-operative baseline at specified post-operative visits.
Measured: Postoperative month 3
Secondary outcomes (1)
Number of Participants With Successful Imaging of the Bleb With iOCT
The secondary outcomes will be feasibility of intraoperative OCT. Feasibility will be defined as the percentage of cases with successful imaging of the bleb with iOCT.
Measured: Intraoperative assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start18 Aug 2020
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
Why it stopped: Slow recruitment, lack of availability of equipment, lack of availability of staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelo P Tanna, Northwestern University
- Investigators
- Angelo P Tanna, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790408
- Sponsor's protocol ID
- STU00213080
- Status last verified
- Oct 2023
- First submitted
- 4 Jan 2022
- Last updated
- 15 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Arora KS, Robin AL, Corcoran KJ, Corcoran SL, Ramulu PY. Use of Various Glaucoma Surgeries and Procedures in Medicare Beneficiaries from 1994 to 2012. Ophthalmology. 2015 Aug;122(8):1615-24. doi: 10.1016/j.ophtha.2015.04.015. Epub 2015 Jun 16.
PubMed 26092196Kirwan JF, Lockwood AJ, Shah P, Macleod A, Broadway DC, King AJ, McNaught AI, Agrawal P; Trabeculectomy Outcomes Group Audit Study Group. Trabeculectomy in the 21st century: a multicenter analysis. Ophthalmology. 2013 Dec;120(12):2532-2539. doi: 10.1016/j.ophtha.2013.07.049. Epub 2013 Sep 23.
PubMed 24070811Mastropasqua R, Fasanella V, Agnifili L, Curcio C, Ciancaglini M, Mastropasqua L. Anterior segment optical coherence tomography imaging of conjunctival filtering blebs after glaucoma surgery. Biomed Res Int. 2014;2014:610623. doi: 10.1155/2014/610623. Epub 2014 Jul 20.
PubMed 25136603Hamanaka T, Omata T, Sekimoto S, Sugiyama T, Fujikoshi Y. Bleb analysis by using anterior segment optical coherence tomography in two different methods of trabeculectomy. Invest Ophthalmol Vis Sci. 2013 Oct 3;54(10):6536-41. doi: 10.1167/iovs.13-12439.
PubMed 23989189Kojima S, Inoue T, Kawaji T, Tanihara H. Filtration bleb revision guided by 3-dimensional anterior segment optical coherence tomography. J Glaucoma. 2014 Jun-Jul;23(5):312-5. doi: 10.1097/IJG.0b013e3182741ee6.
PubMed 23377583Ehlers JP, Modi YS, Pecen PE, Goshe J, Dupps WJ, Rachitskaya A, Sharma S, Yuan A, Singh R, Kaiser PK, Reese JL, Calabrise C, Watts A, Srivastava SK. The DISCOVER Study 3-Year Results: Feasibility and Usefulness of Microscope-Integrated Intraoperative OCT during Ophthalmic Surgery. Ophthalmology. 2018 Jul;125(7):1014-1027. doi: 10.1016/j.ophtha.2017.12.037. Epub 2018 Mar 2.
PubMed 29409662Dada T, Angmo D, Midha N, Sidhu T. Intraoperative Optical Coherence Tomography Guided Bleb Needling. J Ophthalmic Vis Res. 2016 Oct-Dec;11(4):452-454. doi: 10.4103/2008-322X.194150.
PubMed 27994819Kumar RS, Jariwala MU, V SA, Venugopal JP, Puttaiah NK, Balu R, Rao A S D, Shetty R. A Pilot Study on Feasibility and Effectiveness of Intraoperative Spectral-Domain Optical Coherence Tomography in Glaucoma Procedures. Transl Vis Sci Technol. 2015 Mar 9;4(2):2. doi: 10.1167/tvst.4.2.2. eCollection 2015 Mar.
PubMed 25767745Cantor LB, Mantravadi A, WuDunn D, Swamynathan K, Cortes A. Morphologic classification of filtering blebs after glaucoma filtration surgery: the Indiana Bleb Appearance Grading Scale. J Glaucoma. 2003 Jun;12(3):266-71. doi: 10.1097/00061198-200306000-00015.
PubMed 12782847
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior-segment OCT (AS-OCT) and Intraoperative OCT (iOCT) for Trans- Conjunctival Needle Revision (TCNR) of Trabeculectomy Bleb
- ClinicalTrials.gov ID
- NCT05790408
- Acronym / sponsor ID
- STU00213080
- Conditions
- Glaucoma, Glaucoma Following Surgery
- Keywords
- optical coherence tomography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment, lack of availability of equipment, lack of availability of staff
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Posted 15 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trabeculectomy is a very important and commonly performed glaucoma operation. It allows fluid from inside the eye to exit into a space called a bleb located on the surface of the eye under the upper eyelid. The formation of excessive scar tissue after surgery may cause the operation to work less well or stop working. This results in an increase in eye pressure. The use of a needle to cut the scar tissue is a commonly used procedure. This surgery is called trans-conjunctival needle revision (TCNR) of trabeculectomy bleb.
The study aims to determine if advanced optical imaging called Optical Coherence Tomography (OCT) of the scar tissue both in the office prior to surgery and during surgery in the operating room improves the success rate of the revision surgery. These devices are FDA approved and have been used extensively in ophthalmology and ocular surgery.
Ophthalmologists already used these imaging devices for this purpose as part of the standard medical care of some patients. The purpose of this study is to prospectively gather information about its use in a systematic way. Furthermore, investigators want to determine if imaging improves outcomes compared to historical controls (patients who underwent the same surgery in the past without imaging). The potential benefit of this research is that it may provide knowledge that will be of benefit to future patients with glaucoma who are undergoing this procedure.
Detailed description
Trabeculectomy is one of the most commonly performed glaucoma procedures performed to control IOP with approximately 18,000 operations performed in US Medicare beneficiaries alone in 2012. One complication of trabeculectomy surgery is the formation of subconjunctival and episcleral fibrosis, which occurs as part of the wound healing process and can result in fibrosis of the filtering bleb and failure. Transconjunctival needle revision (TCNR) aims to lyse subconjunctival adhesions and reestablish adequate aqueous humor flow from the anterior chamber to the subconjunctival space. One study reported 17% of trabeculectomies require bleb-needling revision. During TCNR the surgeon is able to visualize the trajectory of the needle or blade under the conjunctiva; however, detection of the fibrotic tissue and determination as to whether that tissue has been adequately lysed is difficult, limiting the success rate of the procedure.
Anterior segment optical coherence tomography (AS-OCT) allows for detailed assessment of the internal morphology of the bleb. Studies have utilized AS-OCT to assess morphological features of the bleb and correlate it with surgical success. A small case series reported the utility of AS-OCT for pre-operative planning for bleb revision, in particular, identifying safe access sites and minimizing conjunctival dissection.
More recently, real time OCT integrated with operative microscope has become available. Intraoperative OCT (iOCT) has been utilized extensively in retinal surgery and corneal surgery. Dada et al., described performing iOCT-guided TCNR in 2 patients with failed trabeculectomy blebs without intraoperative or postoperative complications. Investigators reported they were able to obtain a detailed view of the bleb wall and assess the depth and location of the needle, which permitted better lysis of adhesions. A pilot study by Kumar et al., reported one case of TCNR in which iOCT was used to demonstrate the extent of adhesions and loculations inside the bleb at the beginning of the procedure, and the lysis of these adhesions and formation of large single hyporeflective cavity inside the bleb at the end of the procedure. These small case studies suggest a role of iOCT imaging for TCNR, however, further research is needed to assess its feasibility and utility for routine use.
The aim of the research is to assess the surgical success, feasibility and utility of pre-operative Anterior Segment Optical Coherence Tomography (AS-OCT) and intraoperative Optical Coherence Tomography (iOCT) in trans-conjunctival needle revision (TCNR) of trabeculectomy bleb. Furthermore, investigators want to assess whether AS-OCT can be used to identify characteristics of trabeculectomy blebs that are associated with successful surgical outcomes.
To undergo this study, investigators will conduct a prospective study of patients who consent to AS-OCT and iOCT revision of TCNR. Investigators will compare the outcomes of these patients with retrospectively identified, historical controls (i.e. patients who underwent TCNR by the same surgeon without AS-OCT or iOCT assistance).
investigators hypothesize that information gained from pre-operative AS-OCT and intraoperative OCT will aid with intraoperative decision-making for TCNR of trabeculectomy bleb and will thereby improve surgical outcomes. Investigators also hypothesize that preoperative AS-OCT can be used to identify features of trabeculectomy bleb that can predict success with iOCT-assisted TCNR. More specifically, investigators hypothesize that filtering blebs with more extensive scarring as seen on pre-operative AS-OCT will benefit from iOCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AS-OCT and iOCT | Other | Device: Digital microscope integrated with intraoperative OCT (Zeiss Artevo 800, Carl Zeiss Meditec AG), Device: Spectralis Anterior-segment OCT (AS-OCT) (Heidelberg Engineering)This prospective study will include approximately 25 patients with open-angle glaucoma who will undergo TCNR of trabeculectomy bleb by a glaucoma specialist at Northwestern Medicine. These patients will have a history of glaucoma and failed trabeculectomy bleb (as evidenced by clinical features and elevated IOP). During routine clinic visit, the patient will undergo lit lamp grading of bleb by Indiana Bleb Appearance Grading Score (IBAGS). Subjects who agree to participate and provide written informed consent will undergo AS-OCT imaging (Spectralis OCT, Heidelberg) of the bleb. During their operation, the Zeiss Artevo digital microscope integrated with iOCT (Zeiss Artevo 800, Carl Zeiss Meditec AG), a commercially available device will be utilized to visualize and evaluate the morphology of the trabeculectomy bleb at the start and conclusion of the case. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Briefly, the diagnosis of glaucoma is based on the presence of 2 or more of the following findings: 1) glaucomatous optic disc damage, defined as the presence of optic disc excavation, diffuse or focal neuroretinal rim thinning or notching, localized or generalized retinal nerve fiber layer (RNFL) thinning; 2) visual field defects consistent with glaucoma; and 3) IOP ≥ 22 mmHg.
- Patients with glaucoma who have been advised to undergo TCNR of a failed trabeculectomy bleb by a glaucoma specialist at Northwestern Medicine
- History of failed trabeculectomy (based on clinical features of the trabeculectomy bleb and elevated intraocular pressure)
- Patients can have history of other glaucoma surgery or cataract surgery
- The diagnosis of glaucoma is based on the presence of 2 or more of the following findings: 1) glaucomatous optic disc damage, defined as the presence of optic disc excavation, diffuse or focal neuroretinal rim thinning or notching, localized or generalized RNFL thinning; 2) visual field defects consistent with glaucoma; and 3) IOP ≥ 22 mmHg.
Key exclusion criteria (5 listed)
- Age younger than 18 years;
- Secondary causes of glaucoma (e.g., iridocyclitis, trauma);
- Any evidence of corneal or conjunctival pathology adjacent to filtration bleb that could influence AS-OCT image
- Patients who did not undergo surgery or have adequate follow up
- Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and vulnerable populations
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 |
|---|---|---|
| Digital microscope integrated with intraoperative OCT (Zeiss Artevo 800, Carl Zeiss Meditec AG)The Zeiss Artevo digital microscope integrated with iOCT (Zeiss Artevo 800, Carl Zeiss Meditec AG) is a commercially available, FDA approved device that can be utilized to visualize and evaluate the morphology of the trabeculectomy bleb during transconjunctival needle revision of trabeculectomy bleb. | Device | AS-OCT and iOCT |
| Spectralis Anterior-segment OCT (AS-OCT) (Heidelberg Engineering)The Spectralis Anterior-segment OCT (AS-OCT) is a commercially available, FDA approved device that can be utilized to visualize and evaluate the morphology of the trabeculectomy bleb in the office. | Device | AS-OCT and iOCT |
Primary outcome
Surgical Success
Time frame: Postoperative month 3
Surgical success as defined as a 20% reduction in unmedicated IOP below the pre-operative baseline at specified post-operative visits.
1 secondary outcome
Number of Participants With Successful Imaging of the Bleb With iOCT
Time frame: Intraoperative assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26092196Arora KS, Robin AL, Corcoran KJ, Corcoran SL, Ramulu PY. Use of Various Glaucoma Surgeries and Procedures in Medicare Beneficiaries from 1994 to 2012. Ophthalmology. 2015 Aug;122(8):1615-24. doi: 10.1016/j.ophtha.2015.04.015. Epub 2015 Jun 16.
- Background: PubMed 24070811Kirwan JF, Lockwood AJ, Shah P, Macleod A, Broadway DC, King AJ, McNaught AI, Agrawal P; Trabeculectomy Outcomes Group Audit Study Group. Trabeculectomy in the 21st century: a multicenter analysis. Ophthalmology. 2013 Dec;120(12):2532-2539. doi: 10.1016/j.ophtha.2013.07.049. Epub 2013 Sep 23.
- Background: PubMed 25136603Mastropasqua R, Fasanella V, Agnifili L, Curcio C, Ciancaglini M, Mastropasqua L. Anterior segment optical coherence tomography imaging of conjunctival filtering blebs after glaucoma surgery. Biomed Res Int. 2014;2014:610623. doi: 10.1155/2014/610623. Epub 2014 Jul 20.
- Background: PubMed 23989189Hamanaka T, Omata T, Sekimoto S, Sugiyama T, Fujikoshi Y. Bleb analysis by using anterior segment optical coherence tomography in two different methods of trabeculectomy. Invest Ophthalmol Vis Sci. 2013 Oct 3;54(10):6536-41. doi: 10.1167/iovs.13-12439.
- Background: PubMed 23377583Kojima S, Inoue T, Kawaji T, Tanihara H. Filtration bleb revision guided by 3-dimensional anterior segment optical coherence tomography. J Glaucoma. 2014 Jun-Jul;23(5):312-5. doi: 10.1097/IJG.0b013e3182741ee6.
- Background: PubMed 29409662Ehlers JP, Modi YS, Pecen PE, Goshe J, Dupps WJ, Rachitskaya A, Sharma S, Yuan A, Singh R, Kaiser PK, Reese JL, Calabrise C, Watts A, Srivastava SK. The DISCOVER Study 3-Year Results: Feasibility and Usefulness of Microscope-Integrated Intraoperative OCT during Ophthalmic Surgery. Ophthalmology. 2018 Jul;125(7):1014-1027. doi: 10.1016/j.ophtha.2017.12.037. Epub 2018 Mar 2.
- Background: PubMed 27994819Dada T, Angmo D, Midha N, Sidhu T. Intraoperative Optical Coherence Tomography Guided Bleb Needling. J Ophthalmic Vis Res. 2016 Oct-Dec;11(4):452-454. doi: 10.4103/2008-322X.194150.
- Background: PubMed 25767745Kumar RS, Jariwala MU, V SA, Venugopal JP, Puttaiah NK, Balu R, Rao A S D, Shetty R. A Pilot Study on Feasibility and Effectiveness of Intraoperative Spectral-Domain Optical Coherence Tomography in Glaucoma Procedures. Transl Vis Sci Technol. 2015 Mar 9;4(2):2. doi: 10.1167/tvst.4.2.2. eCollection 2015 Mar.
- Background: PubMed 12782847Cantor LB, Mantravadi A, WuDunn D, Swamynathan K, Cortes A. Morphologic classification of filtering blebs after glaucoma filtration surgery: the Indiana Bleb Appearance Grading Scale. J Glaucoma. 2003 Jun;12(3):266-71. doi: 10.1097/00061198-200306000-00015.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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.
Angelo P Tanna, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital microscope integrated with intraoperative OCT (Zeiss Artevo 800, Carl Zeiss Meditec AG) and Spectralis Anterior-segment OCT (AS-OCT) (Heidelberg Engineering) in people with Glaucoma and Glaucoma Following Surgery, run by Northwestern University at 1 site in United States.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 Nov 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Surgical Success (time frame: Postoperative month 3). 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 NCT05790408, which also lists 9 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 Nov 2023.