Evaluation of Phacogoniotomy in Medically-controlled POAG
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorSun Yat-sen University
About this trial
The goal of this multicenter non-inferiority randomized controlled trial is to compare the efficacy of phacoemulsification with intraocular lens implantation (PEI) combined with goniotomy (GT) and PEI combined with medical therapy (MED) in the treatment of medically-controlled primary open-angle glaucoma (POAG) with cataract. The main questions it aims to answer are:
* Whether the PEI+GT was non-inferior to PEI+MED with regard to the intraocular pressure lowering effect in medically-controlled POAG. * Whether the PEI+GT has value of health economics. Participants will be randomized to receive either PEI+GT or PEI+MED, and followed up with a 1-year period as a primary outcome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
40 ≤ Age ≤ 85 years, gender unrestricted.
Diagnosed with POAG.
Controlled IOP under 1 to 4 topical hypotensive medications, IOP ≤ 24 mmHg
Mean deviation (MD) for perimetry ≥ -16dB.
Disqualifiers
Any history of intraocular surgery or ocular trauma.
Presence of other types of glaucoma, including primary angle-closure glaucoma and various forms of secondary glaucoma (e.g. secondary angle-closure, pigmentary, steroid-induced, angle-recession, neovascular, inflammatory, and pseudoexfoliation syndrome).
Presence of severe ocular diseases of various types that affect the acquisition of ocular parameters or interfere with perimetry.
Axial length > 28 mm.
Trial design
Design model
Parallel
Treatments tested in this trial
PEI+GT
Procedure/SurgeryAfter a standard phacoemulsification with intraocular lens implantation (PEI) is performed. The viscoelastic substance will be injected into the anterior chamber again to maintain corneal rigidity. The surgical microscope will be adjusted to tilt 35-40° towards the patient's nasal side, and the patient's head position will be adjusted to tilt 35-40° accordingly. A viscoelastic substance will be applied to the corneal surface to facilitate direct visualization of the angle structures under a gonioscope. The Tanito Microhook will be inserted through the main incision into the anterior chamber, and under gonioscopic guidance, the nasal (or inferonasal) trabecular meshwork and the inner wall of Schlemm's canal will be incised, approximately 120° in extent (60° in each direction).
PEI+MED
Procedure/SurgeryParticipants assigned to control group will undergo routine PEI surgery. Postoperatively, the decision to administer anti-glaucoma medication is based on intraocular pressure (IOP) measurements, and the target IOP is set at 16 mmHg. The selection of medications is informed by the Asia Pacific Glaucoma Guidelines (Kugler Publications, 2016), while the target IOP reference is the European Glaucoma Guidelines.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PEI+GTExperimental treatment 1 intervention
Group B: PEI+MEDActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
IOP at 12 months after surgery.
The intraocular pressure (mmHg) at 12 months after surgery.
Time frame
Postopertive 12 months.Secondary outcomes
1
Surgery success of surgery
(i) Complete success (%) is defined as the postoperative 5 \< IOP ≤ 16 mmHg with no need for IOP-lowering medication, without any vision-threatening complication or need for re-operation. (ii) Qualified success (%) is defined as the postoperative 5 \< IOP ≤ 16 mmHg regardless of IOP-lowering medication, without any vision-threatening complication or need for re-operation.
Time frame
Postoperative 3, 6, 12 months.2
Amount of postoperative anti-glaucomatous medications
The amount of postoperative anti-glaucomatous medications will be measured as: types of medication (No.) × time (No.).
Time frame
Postoperative 1, 3, 6, 12 months.3
Cost-effectiveness associated parameters
Cost-effectiveness associated parameters: cost of surgery and medications; quality-adjusted life year, etc.
Time frame
Postoperative 12 months.Other outcomes
1
Surgery complications
Incidence of surgery complications.
Time frame
Postoperative 1, 3, 6, 12 months.2
Visual acuity
Unit: logMAR
Time frame
Postoperative 1, 3, 6, 12 months.3
Corneal endothelial cell counting
Unit: cells/mm\^2
Time frame
Postoperative 12 months.4
Visual field
Mean deviation (MD) and pattern standard deviation (PSD) using Humphrey perimetery
Time frame
Postoperative 12 months.Sponsors and contacts
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Sun Yat-sen University
Lead sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor institution
West China Hospital
Collaborator
Chongqing Medical University
Collaborator
The Second Hospital of Anhui Medical University
Collaborator
Handan City Eye Hospital
Collaborator
Shijiazhuang People's Hospital
Collaborator
Chengdu First People's Hospital
Collaborator
Guangdong Hospital of Traditional Chinese Medicine, Zhuhai
Collaborator
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Collaborator
Huizhou Municipal Central Hospital
Collaborator
Source ClinicalTrials.gov