Anterior Lens Capsule as a Spacer in the Deep Sclerectomy _ Phacoemulsification

Cataract Clinical Trial

Official title:

Use of Anterior Lens Capsule as a Spacer in the Deep Sclerectomy _ Phacoemulsification: A Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05906212
• Other study ID #: 14021
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 16, 2023
• Est. completion date: June 16, 2024

Study information

• Verified date: June 2023
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: June 16, 2024
• Est. primary completion date: May 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Glaucoma

Intervention

Procedure:
• Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule
This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification with autotransplantation of anterior lens capsule.
• Non-penetrating deep sclerectomy and phacoemulsification
This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification alone.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baselines and month 1 follow up
Primary	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	Baselines and month 3 follow up
Primary	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	Baselines and month 6 follow up
Primary	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	Baselines and month 12 follow up
Secondary	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.	Month 3 follow up
Secondary	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.	Month 1 follow up
Secondary	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.	Month 6 follow up
Secondary	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.	Month 12 follow up
Secondary	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.	Month 3 follow up
Secondary	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.	Month 6 follow up
Secondary	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.	Month 12 follow up
Secondary	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.	Month 1 follow up
Secondary	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.	Baseline and month 1 follow up
Secondary	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.	Baseline and month 3 follow up
Secondary	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.	Baseline and month 6 follow up
Secondary	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.	Baseline and month 12 follow up
Secondary	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.	Baseline and month 6 follow up
Secondary	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.	Baseline and month 12 follow up
Secondary	Complications at month 1 follow up	The complications of surgery will be assessed at month 1 follow up.	Month 1 follow up
Secondary	Complications at month 3 follow up	The complications of surgery will be assessed at month 3 follow up.	Month 3 follow up
Secondary	Complications at month 6 follow up	The complications of surgery will be assessed at month 6 follow up.	Month 6 follow up
Secondary	Complications at month 12 follow up	The complications of surgery will be assessed at month 12 follow up.	Month 12 follow up
Secondary	Need to postoperative needling and laser goniopuncture at month 1 follow up	Need to postoperative needling and laser goniopuncture at month 1 follow up	Month 1 follow up
Secondary	Need to postoperative needling and laser goniopuncture at month 3 follow up	Need to postoperative needling and laser goniopuncture at month 3 follow up	Month 3 follow up
Secondary	Need to postoperative needling and laser goniopuncture at month 6 follow up	Need to postoperative needling and laser goniopuncture at month 6 follow up	Month 6 follow up
Secondary	Need to postoperative needling and laser goniopuncture at month 12 follow up	Need to postoperative needling and laser goniopuncture at month 12 follow up	Month 12 follow up