Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04673201 |
| Other study ID # |
R.20.11.1083 - 2020/11/20 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 21, 2020 |
| Est. completion date |
June 2021 |
Study information
| Verified date |
December 2020 |
| Source |
Mansoura University |
| Contact |
Amr M Abdelkader, MD |
| Phone |
1004314242 |
| Email |
dramrabdelkader[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose:
To assess the safety and efficacy of Viscotrabeculotomy Versus trabeculectomy with MMC for
the management of medically uncontrolled steroid induced glaucoma.
Patients and methods:
A retrospective review of 86 eyes of 67 patients with medically uncontrolled SIG who
underwent either viscotrabeculotomy (VT) or trabeculectomy with MMC (Trab-MMC) at Mansoura
Ophthalmic Center (Mansoura, Egypt) between January 2008, and December 2017 was conducted.
Keywords:
Steroid induced glaucoma, trabeculectomy, trabeculotomy and MMC.
Description:
Introduction:
Steroid induced glaucoma(SIG) is a form of open-angle glaucoma associated with various
modalities of corticosteroid administration such as oral, intravenous, inhaled, ocular
instilled, intravitreal, and periocular u.Some histologic studies have reported the
accumulation of extracellular matrices including basement membrane-like material, fine
fibrillar-like material or proteoglycans in the trabecular meshwork (TM) of SIG patients.
These observations suggest that such accumulation could lead to an increased resistance to
aqueous outflow in the TM of SIG patients.Surgical procedures for intraocular pressure (IOP)
reduction in eyes with SIG include trabeculectomy, trabeculotomy,viscocanalostomy and laser
trabeculoplasty. Although several case series have shown that these surgeries are effective
for IOP reduction, surgical outcomes for SIG are not fully understood due to lack of large
case-control studies aiming to investigate the success rates of trabeculotomy in SIG eyes.It
has previously been reported that trabeculotomy more effectively reduces IOP in adult
Japanese patients with exfoliative glaucoma than in primary open-angle glaucoma (POAG).This
IOP lowering effect in eyes with exfoliative glaucoma is thought to be attributable to the
relief of abnormally increased outflow resistance that was induced by the accumulation of
exfoliative material within the TM. For the same reason, trabeculotomy has been the surgical
procedure of choice for adult patients with SIG among Japanese surgeons.Honjo etal previously
showed that trabeculotomy helped to reduce IOPs to 21 mm Hg or less in 14 Japanese patients
with SIG. However, some questions still without answers for example, whether trabeculotomy
with its modifications for SIG offers better IOP management than other surgeries such as
trabeculectomy with mitomycin C (MMC), or which characteristics of patients with SIG show
better prognosis after trabeculotomy. Therefore the purpose of this retrospective study was
to compare the long term surgical outcomes of viscotrabeculectomy(VT) and trabeculectomy with
mitomycin C (Trab-MMC) in patients with uncontrolled steroid induced glaucoma.
Subjects and methods:
A retrospective review of 86 eyes of 67 patients with medically uncontrolled SIG who
underwent either viscotrabeculotomy (VT) or trabeculectomy with MMC (Trab-MMC) at Mansoura
Ophthalmic Center (Mansoura, Egypt) between January 2008, and December 2017 was conducted.
The research conformed to the provisions of the Declaration of Helsinki. The confidentiality
of the data was ensured. The VT group included 45 eyes and the Trab-ologen group included 41
eyes.
Demographic and clinical data were retrieved from the records such as age at surgery, gender,
best-corrected visual acuity (BCVA, LogMAR), intraocular pressure (IOP), gonioscopy, number
of glaucoma medications, surgical details and postoperative complications. Steroid-induced
glaucoma eyes were defined as open-angle eyes with an IOP elevation of 22 mm Hg or more after
the administration of corticosteroid. Glaucoma surgery was performed when IOP was
persistently elevated despite maximal tolerated IOP-lowering therapy with potential or actual
compromise of optic nerve structure (progressive optic nerve cupping) and/or function
(deterioration of visual field testing). All patients were required to sign informed consent
forms before surgery.
Viscotrabeculotomy (VT) performed in this study involved the creation of a partial thickness
(about 50% thickness) quadrangular (4x4 mm) scleral flap, followed by localization of
Schlemm's canal by radial incisions straddling the limbus. High viscosity sodium hyaluronate
(Healon GV, Pfizer, NY, USA) was then slowly injected into both ends of Schlemm's canal.
Trabeculotomy was completed using the standard metal Harm's trabeculotome (Geuder
Instruments, Heidelberg, Germany). Rotation of these probes achieved 120-degree opening of
the trabecular meshwork. Next, a small amount of sodium hyaluronate was injected through the
open ends of the canal of Schlemm and along the trabeculotomy openings. The scleral flap was
then secured tightly with interrupted 10/0 Nylon sutures and conjunctival closure ensued.
Trabeculectomy technique involved a creation of a limbal-based conjunctival flap, followed by
creation of a 3 x 4 rectangular half-thickness sclera flap. MMC was applied in a
concentration of 0.03% for 3 minutes through soaked surgical sponge inserted underneath the
conjunctival flap and spread of a large surface area posterior to the limbus and planned
scleral flap site then thoroughly irrigated by 200mL of sterile normal saline. The procedure
was completed in the usual manner with both sclera and conjunctiva closed by 10/0 nylon
sutures. Postoperative treatment for both groups consisted of topical steroids
(dexamethasone) and antibiotic (ofloxacin) five times a day with gradual taper over a period
of 5 weeks.
Surgical success was defined at the end of the 4 years of follow up as an IOP between 6 and
21 mmHg and /or IOP reduction greater than 35 % of baseline throughout the entire follow-up
period. Absolute success was defined as success being achieved without medications, and
qualified success was defined as achieving success with adjunctive medications. Failure was
defined as not meeting the above criteria, or any return to the operating theatre for
glaucoma reoperation, or loss of vision to no light perception or hypotony (IOP <6 mmHg on 2
occasions after 3 months from the operation). A minimum follow-up of 3 years was required for
inclusion in the study.
During the follow up period, eyes that were labelled as "Failure" at any follow up time point
were excluded from the data analysis from that follow up time point to the end of the study
period (48 months). Follow up was maintained to the patient as part of the patient care
service routinely provided by the study setting. The patients' postoperative data was
collected from records at day 1, week 1, month 1, month 3, month 6, month 12, month 18, month
24, month 30, month 36 and month 48.
