Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma

Congenital Cataract Clinical Trial

Official title:

A Novel Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma After Congenital Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03610295
• Other study ID #: 2018KYPJ091
• Status: Completed
• Phase: N/A
• Start date: August 2, 2018
• Est. completion date: March 5, 2019

Study information

• Verified date: March 2019
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a retrospective, nonrandomized comparative trial with historical control to investigate the safety and efficacy of a novel progressive grasping peripheral iridectomy (PGPI) surgical method in preventing aphakic angle-closure glaucoma (AACG) following congenital cataract surgery.

Description:

Aphakic angle-closure glaucoma (AACG) following congenital cataract surgery is a common and serious complication which can be prevented by prophylactic peripheral iridectomy (PPI). However, it is difficult to perform routine PPI via scleral tunnel incision especially when the pupil is dilated. Here, the investigators designed a novel progressive grasping peripheral iridectomy (PGPI) surgical method which can ensure the accurate iridectomy position and minimize the complication. The aim of this study is to assess the safety and efficacy of the PGPI in preventing AACG following congenital cataract surgery.

This is a retrospective, nonrandomized comparative trial with historical control. The congenital cataract patients performed with cataract extraction combined with PPI (PPI group) and the patients performed with cataract extraction alone and leaving the iris intact (historical control group) were enrolled and a retrospective medical chart review was conducted. The IOP, anterior chamber depth, corneal clarity, patency of peripheral iridectomy opening, and the rate of AACG, iris posterior synechia (IPS) and visual axis opacity (VAO) were compared between two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: March 5, 2019
• Est. primary completion date: March 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 24 Months

Eligibility

Inclusion Criteria:

1. patients less than 2 years old;

2. patients performed with congenital cataract surgery with or without PPI;

3. patients with routine follow-up at ZOC.

Exclusion Criteria:

1. patients with IOP =21 mm Hg or with congenital glaucoma or with a family history of glaucoma;

2. patients with keratopathy, retinopathy, ocular trauma, radiation therapy or intraocular surgery;

3. patients associated with other congenital ocular anomalies, such as anterior segment dysgenesis, microcornea/microphthalmia, persistent fetal vasculature, lens dislocation and iridocoloboma;

4. patients with systemic diseases, such as Down's syndrome, Lowe syndrome, Stickler syndrome, maternal rubella syndrome or trisomy 13.

Related Conditions & MeSH terms

• Aphakic Glaucoma
• Cataract
• Congenital Cataract
• Glaucoma
• Glaucoma, Angle-Closure

Intervention

Procedure:
• PPI group
The patients underwent cataract extraction, posterior capsulotomy, anterior vitrectomy combined with prophylactic peripheral iridectomy.
• cataract extraction
The patients underwent cataract extraction, posterior capsulotomy combined with anterior vitrectomy and leave the iris intact.

Locations

Country	Name	City	State
China	State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong
China	Zhongshan Ophthalmic Center, Sun Yet-san University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of aphakic angle-closure glaucoma	Pupillary block with subsequent closure of the filtration angle is the cause of early aphakic angle-closure glaucoma (AACG), which usually happens in the early postoperative period, generally within the first 6 months. AACG presents with elevated IOP (repeatedly >25 mmHg), corneal edema, iris bombe, shallow anterior chamber, peripheral anterior synechia and angle closure.	18-49 months
Secondary	The rate of iris posterior synechia	Postoperative uveal inflammation can result in iris posterior synechia (IPS), referring to the synechia between iris and capsule around pupil. IPS is graded according to the range of the synechia. Grade 0: no synechia; Grade I: <1 quadrant; Grade II: =2 quadrants and >1 quadrant ; Grade III: =3 quadrants and >2 quadrants; Grade IV: >3 quadrants.	18-49 months
Secondary	The rate of visual axis opacity	visual axis opacification (VAO) refers to developing reopacification of the visual axis in the form of lens proliferation into the visual axis or pupillary membrane.	18-49 months