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Status unknownNCT04703712Updated Mar 1, 2023

Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy

An interventional study of Lens extraction combined with goniosynechialysis and Trabeculectomy surgery in Glaucoma, Angle-Closure, sponsored by Eye & ENT Hospital of Fudan University. Status unknown at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by Eye & ENT Hospital of Fudan University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
316
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

To compare the effectiveness of lens extraction combined with goniosynechialysis and trabeculectomy in treating advanced angle-closure glaucoma.

Read the detailed description

Advanced angle closure glaucoma (AACG) can result in severe visual function defect or even blindness with or without acute attacks. Different from open angle glaucoma (OAG), the main principle of treatment for AACG is not only to lower intraocular pressure (IOP) but also to protect the anterior chamber angle from closing. Previously, the most common and classical treatment for AACG was trabeculectomy. However, both doctors and patients are not satisfied with this surgery because of its limited success rate due to fibrosis of the filtration pathway. Besides, trabeculectomy has various complications, such as shallow anterior chamber, choroidal effusion, suprachoroidal hemorrhage, malignant glaucoma, and bleb leakage associated endophthalmitis. In addition, patients who underwent trabeculectomy will have decreased visual acuity in a couple of years due to accelerated development of cataract. Since a thickened and anterior-positioned lens could play a crucial role in the pathogenesis of AACG, cataract surgery has also been used. Accumulative evidence shows lens extraction alone is an efficient way in treating the early stage of ACG but has limited success rate in AACG. Lens extraction combined with goniosynechialysis (LEG) has been proved to be better than lens extraction alone in re-opening the anterior chamber angle for ACG patients with extensive peripheral anterior synechia and possibly have better effect than trabeculectomy as well from our preliminary data, which has not been proved yet. Thus, this investigation is designed to compare the effect of LEG and trabeculectomy in AACG patients prospectively in 3 years of follow-up. The investigators hypothesize that LEG could have better IOP control and better visual function than trabeculectomy in long term for AACG patients.

02

Conditions studied

  • Glaucoma, Angle-Closure

Keywords

  • phacoemulsification
  • goniosynechialysis
  • trabeculectomy
03

In context

Glaucoma, Angle-Closure

91 studies on the registry are indexed under Glaucoma, Angle-Closure; 17 are open to participants now.

This study's planned enrollment of 316 is above the median of 57 across 58 interventional studies indexed under Glaucoma, Angle-Closure.

Browse Glaucoma, Angle-Closure studies →

Lead sponsor

Eye & ENT Hospital of Fudan University is the lead sponsor of 126 studies on the registry; 70 are open to participants now.

Browse Eye & ENT Hospital of Fudan University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age between 40 years old to 80 years old
  2. more than 180-degree synechial closure of anterior chamber angle on gonioscopy
  3. IOP higher than 21mmHg under the use of more than two anti-glaucoma eye drops
  4. mean deviation of visual field worse than -12dB on Humphrey 24-2
  5. phakic eyes

Exclusion criteria

Exclusion Criteria:

  1. Snellen visual acuity worse than 0.02
  2. history of ocular trauma
  3. uveitis
  4. previous ocular surgeries
  5. significant conjunctival scar
  6. visible neovascular on iris or anterior chamber angle
  7. other severe eye diseases that would affect visual function significantly, such as age-related macular degeneration and pathogenic myopia.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
316 participants (estimated)

Study arms

  • Active comparator
    Lens extraction combined with goniosynechialysis group

    One hundred and fifty-eight patients with advanced angle-closure glaucoma underwent phacoemulsification combined with goniosynechialysis.

    Procedure: Lens extraction combined with goniosynechialysis

  • Active comparator
    Trabeculectomy Group

    One hundred and fifty-eight patients with advanced angle-closure glaucoma underwent trabeculectomy.

    Procedure: Trabeculectomy surgery

Interventions

  • ProcedureLens extraction combined with goniosynechialysis

    The patients enrolled underwent phacoemulsification combined with goniosynechialysis surgery.

  • ProcedureTrabeculectomy surgery

    The patients enrolled underwent trabeculectomy surgery

06

What researchers measure

Primary outcomes

  1. Intraocular pressure (IOP) change at one month

    Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one month.

    Time frame: one month

  2. IOP change at three months

    Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three months.

    Time frame: three months

  3. IOP change at six months

    Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at six months.

    Time frame: six months

  4. IOP change at one year

    Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one year.

    Time frame: one year

  5. IOP change at two years

    Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at two years.

    Time frame: two years

  6. IOP change at three years

    Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three years.

    Time frame: three years

  7. Best corrected visual acuity at one month

    Best corrected visual acuity of participants after surgery at one month

    Time frame: one month

  8. Best corrected visual acuity at three months

    Best corrected visual acuity of participants after surgery at three months

    Time frame: three months

  9. Best corrected visual acuity at six months

    Best corrected visual acuity of participants after surgery at six months

    Time frame: six months

  10. Best corrected visual acuity at one year

    Best corrected visual acuity of participants after surgery at one year

    Time frame: one year

  11. Best corrected visual acuity at two years

    Best corrected visual acuity of participants after surgery at two years

    Time frame: two years

  12. Best corrected visual acuity at three years

    Best corrected visual acuity of participants after surgery at three years

    Time frame: three years

Secondary outcomes

  1. Mean deviation

    The mean deviation value of Humphery visual filed tests before and after surgery.

    Time frame: one month, three months, six months, one year, two years, three years

  2. The thickness of retinal nerve fiber layer (RNFL)

    The RNFL thickness measured by optical coherence topography (OCT)

    Time frame: one month, three months, six months, one year, two years, three years

  3. The thickness of ganglion cell complex (GCC)

    The GCC thickness measured by OCT

    Time frame: one month, three months, six months, one year, two years, three years

  4. Number of eye drops

    The number of eye drops after surgery.

    Time frame: one month, three months, six months, one year, two years, three years

  5. Adverse event

    Adverse events of each group, such as cornea edma, ocular hypotension, hemorrhage

    Time frame: one month, three months, six months, one year, two years, three years

07

Study locations

1 of 1 sites recruiting
  • Eye & ENT Hospital
    Shanghai, 200031, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2021 (actual). Primary completion is estimated for Dec 2024, 47 months after the start.

Of 28 interventional studies with no phase under Glaucoma, Angle-Closure, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 43. This study's planned 47 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 3, 2021
First posted
Jan 11, 2021
StartActual
Jan 30, 2021
Primary completionEst.
Dec 2024
CompletionEst.
Dec 2024
Last update
Mar 1, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04703712
Lead sponsor
Eye & ENT Hospital of Fudan University
Responsible party
Yuhong Chen (Professor, Eye & ENT Hospital of Fudan University) — Principal investigator
First posted
Jan 11, 2021
Start date
Jan 30, 2021
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Mar 1, 2023

Study contacts

Feng Gao, Doctor
Contact
fenggao@fudan.edu.cn
(86)021-64377134

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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