The study will be a Prospective Randomized Control Trial study to assess the efficacy and safety of
Interventional valve enhancing trabeculotomy (iVEnT) versus Kahook Dual Blade (KDB)Goniotomy combined
with phacoemulsification in open angle glaucoma (OAG)
Cataract and Glaucoma occur due to age-related
ocular conditions They together cause the majority of blindness all over the
world For glaucoma patients with visually significant cataract elective
cataract surgery will be an opportunity to improve vision as well as to lower
intraocular pressure (IOP) at the same time Cataract surgery by Phacoemulsification lowers the IOP upto 1to 2mmHg
but when combined with traditional glaucoma surgery it results in better IOP
control Traditional Glaucoma Surgeries are often associated with vision threatening
complications like bleb leak, shallow anterior chamber , choroidal detachment
and bleb-related infections like endophthalmitis. Ab Interno trabeculotomy( a type of MIGS) reduce the IOP in patients with glaucoma by incising or excising a part of the Trabecular meshwork and inner wall of schlemms canal Since there is no bleb formation involved in these procedures vision-threatening complications are less. Therefore the Aim of this study is to compare the Efficacy and Safety of the two Ab Interno Procedures iVEnT and KDB Goniotomy with Phacoemulsification in patients with Open Angle Glaucoma The study will be a Prospective Randomised Control Trial study to assess the efficacy and safety of Interventional valve enhancing trabeculotomy (iVEnT) versus Kahook Dual Blade (KDB)Goniotomy combined with phacoemulsification in open angle glaucoma (OAG)
Primary objective: To evaluate the IOP lowering and Safety Profile
of iVEnT combined with Phacoemulsification
compared to KDB Goniotomy combined with
Phacoemulsification in Open Angle Glaucoma Patient. Secondary objective To
assess the number of Antiglaucoma Medications required postoperatively To
assess complications arising following the procedure. To
measure Schlemms Canal (Area, Width), Ciliary Muscle thickness at 1,2,3 mm
from Scleral spur (CM1, CM2, CM3) using ASOCT CASIA 2 machine
Inclusion criteria
Age 40 to 80 years
Diagnosis of OAG- Mild to moderate POAG Pseudo-exfoliative glaucoma Pigmentary
glaucoma with Visually significant cataract BCVA less than equal to 6 by 12 on snellens chart
Vertical CD ratio less than equal to 0.8
Glaucomatous visual field defects
with MD less than equal to -12dB Pre-op IOP more than equal to 21mmHg or IOP
more than equal to18
mm Hg with AGM
Open angle confirmed by gonioscopy using
4 mirror gonioscopy lens
Able and willing to attend scheduled
follow up visits
Able and willing to provide informed
consent
Non compliance to medication or not
tolerating AGM
Exclusion Criteria
Prior
Glaucoma surgery or laser.
Functionally severe field
loss with a MD of more than -12 dB
Active ocular or periocular inflammation.
Corneal abnormality that may interfere with visualization of angle structures
Traumatic cataract
Retinal or optic nerve disorders that are not associated with existing
glaucoma condition
Elevated episcleral venous pressure
One eyed patients
Study area Glaucoma department of Aravind Eye Hospital, Tirunelveli Tamil Nadu.
Study population Patients coming to Glaucoma OP who are eligible will be included in the study
after obtaining a written informed consent.
Sample size A sample size of 140 eyes ( 70 eyes each
group ) will be required to assess the efficacy and
safety of iVEnT
versus KDB
goniotomy with phacoemulsification in OAG
Study design Prospective, RCT
Study duration 18 months (6 months patient recruitment and 1 year follow up )
Follow up visits at 2 weeks 1 2 3 6 12 months
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