Clinical trial NCT05906212: Anterior Lens Capsule as a Spacer in the Deep Sclerectomy _ Phacoemulsification
Official title: Use of Anterior Lens Capsule as a Spacer in the Deep Sclerectomy _ Phacoemulsification: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Cataract
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized clinical trial, patients with concomitant glaucoma and cataract candidate for non-penetrating deep sclerectomy (NPDS) and phacoemulsification (PE) and subtenon mitomycin injection will be enrolled. Patients will randomly be allocated to two groups \["NPDS and PE and autotransplantation of human anterior lens capsule (ALC)" and "NPDS and PE" alone\]. Exclusion criteria will be the patients with prior ocular surgery, neovascular glaucoma, uveitis, or compromised ocular surface. The intervention group will be undergoing NPDS and PE with the use of an ALC as the spacer in the intrascleral lake. The control group will be undergoing NPDS and PE without any spacer. The primary outcome will be intraocular pressure measured on days 1, 3, 7, months 1, 3, 6, and 12. The secondary outcomes will be surgical success rate (complete and qualified), the number of glaucoma medications, best-corrected visual acuity, surgical complications, and the need for needling and laser goniopuncture measured at the same intervals. The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication. The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication.


Eligibility criteria: Inclusion criteria

* Patients with concomitant uncontrolled glaucoma and significant cataract
* Progression in glaucoma despite medical treatment
* Age more than 18 years old

Exclusion criteria

* Prior ocular surgery
* Neovascular glaucoma or uveitic glaucoma
* Compromised ocular surface or insufficient conjunctiva

Primary outcomes:
measure: Change from baseline intraocular pressure at month 1 follow up
timeFrame: Baselines and month 1 follow up
measure: Change from baseline intraocular pressure at month 3 follow up
timeFrame: Baselines and month 3 follow up
measure: Change from baseline intraocular pressure at month 6 follow up
timeFrame: Baselines and month 6 follow up
measure: Change from baseline intraocular pressure at month 12 follow up
timeFrame: Baselines and month 12 follow up
Secondary outcomes:
measure: The complete success rate at month 3 follow up
timeFrame: Month 3 follow up
measure: The complete success rate at month 1 follow up
timeFrame: Month 1 follow up
measure: The complete success rate at month 6 follow up
timeFrame: Month 6 follow up
measure: The complete success rate at month 12 follow up
timeFrame: Month 12 follow up
measure: The qualified success rate at month 3 follow up
timeFrame: Month 3 follow up
measure: The qualified success rate at month 6 follow up
timeFrame: Month 6 follow up
measure: The qualified success rate at the month 12 follow up
timeFrame: Month 12 follow up
measure: The qualified success rate at the month 1 follow up
timeFrame: Month 1 follow up
measure: Change from baseline the number of glaucoma medications at month 1 follow up
timeFrame: Baseline and month 1 follow up
measure: Change from baseline the number of glaucoma medications at month 3 follow up
timeFrame: Baseline and month 3 follow up
measure: Change from baseline the number of glaucoma medications at month 6 follow up
timeFrame: Baseline and month 6 follow up
measure: Change from baseline the number of glaucoma medications at month 12 follow up
timeFrame: Baseline and month 12 follow up
measure: Change from baseline the best-corrected visual acuity at month 6 follow up
timeFrame: Baseline and month 6 follow up
measure: Change from baseline the best-corrected visual acuity at month 12 follow up
timeFrame: Baseline and month 12 follow up
measure: Complications at month 1 follow up
timeFrame: Month 1 follow up
measure: Complications at month 3 follow up
timeFrame: Month 3 follow up
measure: Complications at month 6 follow up
timeFrame: Month 6 follow up
measure: Complications at month 12 follow up
timeFrame: Month 12 follow up
measure: Need to postoperative needling and laser goniopuncture at month 1 follow up
timeFrame: Month 1 follow up
measure: Need to postoperative needling and laser goniopuncture at month 3 follow up
timeFrame: Month 3 follow up
measure: Need to postoperative needling and laser goniopuncture at month 6 follow up
timeFrame: Month 6 follow up
measure: Need to postoperative needling and laser goniopuncture at month 12 follow up
timeFrame: Month 12 follow up
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References: