Influence of Different Tamponade Eyes on IOL-capsular Complex

Influence of Different Tamponade Eyes on IOL-capsular Complex After Cataract Surgery Combined With Vitrectomy

Cataract and vitreoretinal diseases often occur simultaneously or cataract is a predictable consequence of vitreoretinal surgery.A combined surgery called phacovitrectomy, has been proved to be comparably safe and effective compared with vitrectomy alone. For fundus surgeons, silicone oil（SO）,gas and balanced saline solution are frequently-used intravitreal tamponade mediums for retinal repair after vitrectomy. There are many factors that may affect how the lens changes position after the operation including the different intravitreal tamponade materials and different IOL types. This study was designed to evaluate the differences of IOL position and capsule bending between Silicone oil filled eyes，gas filled eyes, balanced saline solution filled eyes and normal eyes.

The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation. Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity.

Although up to 2-3 degree tilt and a 0.2-0.3 mm decentration are common and clinically unnoticed, larger extent of tilt and decentration has a negative impact on the optical performance. IOL decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were considered clinically significant because of poor post-surgery visual quality.

Currently, there is no literature guidance to compare the results of phacovitrectomy combined various types of intravitreal tamponade materials in patients using CASIA2. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can evaluate the IOL capsule bending and the lens position after cataract surgery. Also, CASIA2 can be used to documented the dynamic changes of IOL-capsular complex after surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract; Vitreoretinal Abnormality
• Intervention / Treatment: Procedure: phacovitrectomy surgery with silicone oil tamponade; Procedure: phacovitrectomy surgery with gas tamponade; Procedure: phacovitrectomy surgery with balanced saline solution tamponade; Procedure: phacoemulsifacation surgery without vitrectomy

Detailed Description

Cataract and vitreoretinal diseases often occur simultaneously or cataract is a predictable consequence of vitreoretinal surgery. Although the optimal treatment for patients with both vitreoretinal and cataract disease is still a matter of debate, a combined surgery called phacovitrectomy, has been proved to be comparably safe and effective compared with vitrectomy alone. For fundus surgeons, silicone oil（SO）,gas and balanced saline solution are frequently-used intravitreal tamponade mediums for retinal repair after vitrectomy. As a biochemically inert polymer, SO is widely used in vitreoretinal surgery and was considered to be well-tolerated and not threatening to retinal physiology. The gases in therapeutic use ([SF6], [C2F6], or [C3F8]) may be mixed with air in vitrectomy or used as 100% gas in pneumatic retinopexy. There are many factors that may affect how the lens changes position after the operation including the different intravitreal tamponade materials and different IOL types. This study was designed to evaluate the differences of IOL position and capsule bending between Silicone oil filled eyes，gas filled eyes, balanced saline solution filled eyes and normal eyes.

The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation. Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity.

Although up to 2-3 degree tilt and a 0.2-0.3 mm decentration are common and clinically unnoticed, larger extent of tilt and decentration has a negative impact on the optical performance. IOL decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were considered clinically significant because of poor post-surgery visual quality.

Currently, there is no literature guidance to compare the results of phacovitrectomy combined various types of intravitreal tamponade materials in patients using CASIA2. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can evaluate the IOL capsule bending and the lens position after cataract surgery. Also, CASIA2 can be used to documented the dynamic changes of IOL-capsular complex after surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patients are diagnosed age related cataract or complicated cataract with or without vitreoretinal diseases
• The patients' age over 50 years old
• The patients plan to receive cataract surgery with or without vitrectomy in Eye hospital of Wenzhou Medical University
• The dilated pupils are over 7mm
• Patients are willing and able to complete the follow-ups.

Exclusion Criteria:

• Patients with other type of cataract
• Patients have severe complications in the surgery and after surgery
• Patients have other severe diseases of eyes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: phacovitrectomy surgery with silicone oil tamponade; patients who had phacovitrectomy surgery with silicone oil tamponade.The patients diagnosed cataract The patients' ages are over 50.	Procedure: phacovitrectomy surgery with silicone oil tamponade; Patients in this study will receive phacovitrectomy surgery with silicone oil tamponade.
EXPERIMENTAL: phacovitrectomy surgery with gas tamponade; patients who had phacovitrectomy surgery with gas tamponade.The patients diagnosed cataract The patients' ages are over 50.	Procedure: phacovitrectomy surgery with gas tamponade; Patients in this study will receive phacovitrectomy surgery with gas tamponade
EXPERIMENTAL: phacovitrectomy surgery with balanced saline solution tamponade; patients who had phacovitrectomy surgery with balanced saline solution tamponade.The patients diagnosed cataract The patients' ages are over 50.	Procedure: phacovitrectomy surgery with balanced saline solution tamponade; Patients in this study will receive phacovitrectomy surgery with balanced saline solution tamponade
EXPERIMENTAL: phacoemulsifacation surgery without vitrectomy; patients who had phacoemulsifacation surgery without vitrectomy.The patients diagnosed cataract The patients' ages are over 50.	Procedure: phacoemulsifacation surgery without vitrectomy; Patients in this study will receive phacoemulsifacation surgery without vitrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The position of IOL	Evaluation of the position of IOL through tilt, decentration，rotation and the process of capsule bending using CAISA2（The novel anterior segment optical coherence tomography (AS-OCT) device）	The 1st day after surgery
The position of IOL	Evaluation of the position of IOL through tilt, decentration，rotation and the process of capsule bending using CAISA2（The novel anterior segment optical coherence tomography (AS-OCT) device）	The 1st week after surgery
The position of IOL	Evaluation of the position of IOL through tilt, decentration，rotation and the process of capsule bending using CAISA2（The novel anterior segment optical coherence tomography (AS-OCT) device）	The 1st month after surgery
The position of IOL	Evaluation of the position of IOL through tilt, decentration，rotation and the process of capsule bending using CAISA2（The novel anterior segment optical coherence tomography (AS-OCT) device）	The 3rd month after surgery

Collaborators and Investigators

• Sponsor: Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2022
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (ACTUAL): March 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Various Types of intravitreal tamponade materials
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: IOL with different tamponade

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No