TerminatedNot Applicable

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

Stopped: Slow recruitment, lack of availability of equipment, lack of availability of staff

United States10 participantsStarted 2020-08-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria * 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. Exclusion criteria * 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, pris…

What they're measuring

Surgical Success

Timeframe: Postoperative month 3

Trial details

NCT IDNCT05790408

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-12

Results submitted2023-04-25