Influence of Different Tamponade Eyes on IOL-capsular Complex

NCT05296486 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-03-25

No results posted yet for this study

Summary

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.

Conditions

  • Cataract
  • Vitreoretinal Abnormality

Interventions

PROCEDURE

phacovitrectomy surgery with silicone oil tamponade

Patients in this study will receive phacovitrectomy surgery with silicone oil tamponade.

PROCEDURE

phacovitrectomy surgery with gas tamponade

Patients in this study will receive phacovitrectomy surgery with gas tamponade

PROCEDURE

phacovitrectomy surgery with balanced saline solution tamponade

Patients in this study will receive phacovitrectomy surgery with balanced saline solution tamponade

PROCEDURE

phacoemulsifacation surgery without vitrectomy

Patients in this study will receive phacoemulsifacation surgery without vitrectomy.

Sponsors & Collaborators

  • Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Yune Zhao · Ophthalmology and Optometry Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-11-01
Completion
2022-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05296486 on ClinicalTrials.gov