Anterior-segment OCT (AS-OCT) and Intraoperative OCT (iOCT) for Trans- Conjunctival Needle Revision (TCNR)

NCT05790408 | Terminated Results FDA Device

• 1 other identifier: STU00213080
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Glaucoma; Glaucoma Following Surgery

Keywords

optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• Surgical Success

  Surgical success as defined as a 20% reduction in unmedicated IOP below the pre-operative baseline at specified post-operative visits.

  Postoperative month 3

Secondary Outcomes (1)

• Number of Participants With Successful Imaging of the Bleb With iOCT

  Intraoperative assessment

Other Outcomes (1)

• Pre-operative AS-OCT Findings

  Pre-operative visit

Study Arms (1)

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.

Device: Digital microscope integrated with intraoperative OCT (Zeiss Artevo 800, Carl Zeiss Meditec AG); Device: Spectralis Anterior-segment OCT (AS-OCT) (Heidelberg Engineering)

Interventions

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.

AS-OCT and iOCT

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.

AS-OCT and iOCT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (9)

• 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.

  PMID: 26092196 BACKGROUND

• Kirwan 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.

  PMID: 24070811 BACKGROUND

• Mastropasqua 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.

  PMID: 25136603 BACKGROUND

• Hamanaka 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.

  PMID: 23989189 BACKGROUND

• Kojima 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.

  PMID: 23377583 BACKGROUND

• Ehlers 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.

  PMID: 29409662 BACKGROUND

• Dada 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.

  PMID: 27994819 BACKGROUND

• Kumar 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.

  PMID: 25767745 BACKGROUND

• Cantor 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.

  PMID: 12782847 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Angelo P. Tanna
• Organization: Northwestern University

atanna@northwestern.edu

3129088152

Study Officials

• Angelo P Tanna, MD

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: March 30, 2023
• Study Start: August 18, 2020
• Primary Completion: January 12, 2022
• Study Completion: January 12, 2022
• Last Updated: November 15, 2023
• Results First Posted: November 15, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)