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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification with autotransplantation of anterior lens capsule.
This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification alone.
Ophthalmic Research Center
Tehran, Iran
Change from baseline intraocular pressure at month 1 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 1 follow up
Time frame: Baselines and month 1 follow up
Change from baseline intraocular pressure at month 3 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 3 follow up
Time frame: Baselines and month 3 follow up
Change from baseline intraocular pressure at month 6 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 6 follow up
Time frame: Baselines and month 6 follow up
Change from baseline intraocular pressure at month 12 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 12 follow up
Time frame: Baselines and month 12 follow up
The complete success rate at month 3 follow up
The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 3 follow up.
Time frame: Month 3 follow up
The complete success rate at month 1 follow up
The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 1 follow up.
Time frame: Month 1 follow up
The complete success rate at month 6 follow up
The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 6 follow up.
Time frame: Month 6 follow up
The complete success rate at month 12 follow up
The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 12 follow up.
Time frame: Month 12 follow up
The qualified success rate at month 3 follow up
The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 3 followup.
Time frame: Month 3 follow up
The qualified success rate at month 6 follow up
The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 6 followup.
Time frame: Month 6 follow up
The qualified success rate at the month 12 follow up
The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 12 followup.
Time frame: Month 12 follow up
The qualified success rate at the month 1 follow up
The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 1 followup.
Time frame: Month 1 follow up
Change from baseline the number of glaucoma medications at month 1 follow up
The number of glaucoma medications will be assessed at baseline and month 1 follow up.
Time frame: Baseline and month 1 follow up
Change from baseline the number of glaucoma medications at month 3 follow up
The number of glaucoma medications will be assessed at baseline and month 3 follow up.
Time frame: Baseline and month 3 follow up
Change from baseline the number of glaucoma medications at month 6 follow up
The number of glaucoma medications will be assessed at baseline and month 6 follow up.
Time frame: Baseline and month 6 follow up
Change from baseline the number of glaucoma medications at month 12 follow up
The number of glaucoma medications will be assessed at baseline and month 12 follow up.
Time frame: Baseline and month 12 follow up
Change from baseline the best-corrected visual acuity at month 6 follow up
The best-corrected visual acuity will be assessed using the Snellen chart at baseline and month 6 follow up.
Time frame: Baseline and month 6 follow up
Change from baseline the best-corrected visual acuity at month 12 follow up
The best-corrected visual acuity will be assessed using the Snellen chart at baseline and month 12 follow up.
Time frame: Baseline and month 12 follow up
Complications at month 1 follow up
The complications of surgery will be assessed at month 1 follow up.
Time frame: Month 1 follow up
Complications at month 3 follow up
The complications of surgery will be assessed at month 3 follow up.
Time frame: Month 3 follow up
Complications at month 6 follow up
The complications of surgery will be assessed at month 6 follow up.
Time frame: Month 6 follow up
Complications at month 12 follow up
The complications of surgery will be assessed at month 12 follow up.
Time frame: Month 12 follow up
Need to postoperative needling and laser goniopuncture at month 1 follow up
Need to postoperative needling and laser goniopuncture at month 1 follow up
Time frame: Month 1 follow up
Need to postoperative needling and laser goniopuncture at month 3 follow up
Need to postoperative needling and laser goniopuncture at month 3 follow up
Time frame: Month 3 follow up
Need to postoperative needling and laser goniopuncture at month 6 follow up
Need to postoperative needling and laser goniopuncture at month 6 follow up
Time frame: Month 6 follow up
Need to postoperative needling and laser goniopuncture at month 12 follow up
Need to postoperative needling and laser goniopuncture at month 12 follow up
Time frame: Month 12 follow up
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