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Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery?

W

Wills Eye

Status and phase

Completed
Phase 3
Phase 2

Conditions

Glaucoma

Treatments

Drug: Triesence
Drug: balanced salt solution BSS

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

The investigators hypothesize that intracameral Triesence during glaucoma surgery will provide lower intraocular pressure through better control of ocular inflammation, thus leading to a more successful filtering procedure.

Full description

Determine the efficacy and safety of intracameral Triesence in patients who undergo trabeculectomy, tube shunt, or combined cataract extraction, intra-ocular lens implantation and trabeculectomy with or without adjunctive mitomycin-C.

Enrollment

77 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • glaucoma patients requiring surgery (Trabeculectomy or Express Shunt; Trabeculectomy plus Phacoemulsification and Interocular Lens Implant; Baerveldt Tube; Ahmed Tube; Molteno Tube)
  • primary open angle glaucoma
  • primary angle-closure glaucoma
  • pseudoexfoliation glaucoma
  • pigmentary glaucoma
  • traumatic glaucoma
  • neovascular glaucoma

Exclusion criteria

  • patients that are pregnant, nursing, or not using adequate contraception
  • any other eye surgery except cataract surgery
  • an infection, inflammation, or any abnormality preventing measurement of eye pressure
  • enrolled in another investigational study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

77 participants in 2 patient groups

Treatment 1(Triesence)
Experimental group
Description:
glaucoma surgery with 0.2cc Triesence adjunct.
Treatment:
Drug: Triesence
Treatment 2 (balanced salt solution BSS)
Active Comparator group
Description:
glaucoma surgery with balanced salt solution, the standard technique.
Treatment:
Drug: balanced salt solution BSS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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