Laser Peripheral Iridotomy Plus Laser Peripheral Iridoplasty for Primary Angle Closure

  • STATUS
    Recruiting
  • End date
    Apr 22, 2022
  • participants needed
    240
  • sponsor
    Sun Yat-sen University
Updated on 22 January 2021

Summary

This is a 10-centre randomized controlled clinical trial to explore whether laser peripheral iridoplasty (LPIP) plus laser peripheral iridotomy (LPI) is more effective than single LPI to control the progression of primary angle closure with multi-mechanism based on the UBM classification.

Details
Condition Angle Closure Glaucoma
Treatment neodymium:yttrium-aluminum- garnet laser, frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser, Pilocarpine, Pilocarpine, LPIP plus LPI, Proparacaine, LPI
Clinical Study IdentifierNCT02613013
SponsorSun Yat-sen University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinical diagnosis of primary angle closure (PAC), with IOP30mmHg and PAS270
PAC with multi-mechanism based on UBM examination (multi-mechanism is defined as primary angle closure is caused by pupil block plus at least one kind of non-pupil block factors like (relative anterior position and thick of the ciliary body, the big volume of the iris, the anterior location of the iris insertion into the ciliary body)or any two or more kinds of combination
Visual acuity 20/40
Age between 40-75 years old Chinese people
If both eyes of a patient are eligible for the study, the e eye had worse
visual acuity will be selected. Only one eye per patient is eligible for the
study
Drug washout
Eligible patients who are already on anti-glaucoma medications are required to
have drug washout before being randomized. Various medications have different
washout periods: Prostaglandin analogues 4 weeks, Beta blockers 3 weeks
Adrenergic agonist 2 weeks, Cholinergic agonist 5 days, Carbonic Anhydrase
Inhibitors 5 days. Patients whose IOP>30 mm Hg during this washout period will
be stopped from further washout and be withdrawn from the study

Exclusion Criteria

Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
Angle closure due to secondary causes (subluxed lens, neovascular, uveitic, traumatic, post-operative)
Previous incisional intraocular surgery or ocular laser in study eye (LPI or LPIP, cyclodestructive procedure, cataract surgery)
Primary angle closure with glaucomatous neuropathy
Have cataract in the studying eye and anticipated to have cataract surgery in the coming 3 years; the existing cataract affect visual field examination and fundus examination; the visual acuity <20/40 due to the existing cataract
Who are using IOP lowing drugs and do not have drug washout
Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for urgent additional ocular surgery
Coexisting other ocular diseases (i.e. cornea abnormal or cornea infection, Iridocorneal endothelial syndrome or anterior segment dysgenesis, nanophthalmos, high myopia (>6.0D), Chronic or recurrent uveitis, ocular cancer, trauma, central retinal vein occlusion, central retinal artery occlusion, retinal detachment)
cornea endothelium counting <1000/mm2
need local or systemic steroid long-term use
Unwilling to discontinue contact lens use after surgery
Who are taking parting in other drug clinical trials
Pregnant or nursing women
Severe systemic disease (i.e. diabetes mellitus, hypertension, the end stage of cardiac disease, nephropathy disease, respiratory disease and cancer
Allergic to pilocarpine or alcaine
Contraindication to ocular laser diseases
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note