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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05906212

Enrollment

Registered

2023-06-15

Start date

2023-05-16

Completion date

2024-06-16

Last updated

2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Glaucoma

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.

Interventions

PROCEDURENon-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.

PROCEDURENon-penetrating deep sclerectomy and phacoemulsification

This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification alone.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline intraocular pressure at month 1 follow up	Baselines and month 1 follow up	The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 1 follow up
Change from baseline intraocular pressure at month 3 follow up	Baselines and month 3 follow up	The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 3 follow up
Change from baseline intraocular pressure at month 6 follow up	Baselines and month 6 follow up	The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 6 follow up
Change from baseline intraocular pressure at month 12 follow up	Baselines and month 12 follow up	The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 12 follow up

Secondary

Measure	Time frame	Description
The qualified success rate at month 3 follow up	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.
The qualified success rate at month 6 follow up	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.
The qualified success rate at the month 12 follow up	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.
The qualified success rate at the month 1 follow up	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.
Change from baseline the number of glaucoma medications at month 1 follow up	Baseline and month 1 follow up	The number of glaucoma medications will be assessed at baseline and month 1 follow up.
Change from baseline the number of glaucoma medications at month 3 follow up	Baseline and month 3 follow up	The number of glaucoma medications will be assessed at baseline and month 3 follow up.
Change from baseline the number of glaucoma medications at month 6 follow up	Baseline and month 6 follow up	The number of glaucoma medications will be assessed at baseline and month 6 follow up.
Change from baseline the number of glaucoma medications at month 12 follow up	Baseline and month 12 follow up	The number of glaucoma medications will be assessed at baseline and month 12 follow up.
Change from baseline the best-corrected visual acuity at month 6 follow up	Baseline and month 6 follow up	The best-corrected visual acuity will be assessed using the Snellen chart at baseline and month 6 follow up.
The complete success rate at month 3 follow up	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.
Complications at month 1 follow up	Month 1 follow up	The complications of surgery will be assessed at month 1 follow up.
Complications at month 3 follow up	Month 3 follow up	The complications of surgery will be assessed at month 3 follow up.
Complications at month 6 follow up	Month 6 follow up	The complications of surgery will be assessed at month 6 follow up.
Complications at month 12 follow up	Month 12 follow up	The complications of surgery will be assessed at month 12 follow up.
Need to postoperative needling and laser goniopuncture at month 1 follow up	Month 1 follow up	Need to postoperative needling and laser goniopuncture at month 1 follow up
Need to postoperative needling and laser goniopuncture at month 3 follow up	Month 3 follow up	Need to postoperative needling and laser goniopuncture at month 3 follow up
Need to postoperative needling and laser goniopuncture at month 6 follow up	Month 6 follow up	Need to postoperative needling and laser goniopuncture at month 6 follow up
Need to postoperative needling and laser goniopuncture at month 12 follow up	Month 12 follow up	Need to postoperative needling and laser goniopuncture at month 12 follow up
Change from baseline the best-corrected visual acuity at month 12 follow up	Baseline and month 12 follow up	The best-corrected visual acuity will be assessed using the Snellen chart at baseline and month 12 follow up.
The complete success rate at month 1 follow up	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.
The complete success rate at month 6 follow up	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.
The complete success rate at month 12 follow up	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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026