Mydriatic Drops After Combined Surgery

Clalit Health Services

Status: Completed

Conditions: Posterior Synechiae of Iris

Treatments: Drug: Cyclopentolate Hydrochloride 1.0% eye drops

Study type: Interventional

Funder types: Other

Identifiers

NCT05614622

0243-20-RMC

Details and patient eligibility

About

The study goal is to evaluate the influence of mydriatic drops on the development of posterior synechia after combined cataract and vitrectomy surgery.

Full description

Cataract and vitreoretinal disorders often coexist, and with up to 80 percent chance for cataract formation following vitreoretinal surgery within the first year, combined surgery of phacoemulsification, pars plana vitrectomy (PPV) and intraocular lens (IOL) implantation has become increasingly accepted.

The main advantages of combined surgery include better visualization during surgery and the elimination of the need for additional surgery, which translates to overall quicker visual recovery and cost-effectiveness. Like the more exercised, two-step procedure, the combined surgery was shown to be safe and effective with relatively few complications. However, one complication seen more frequently after the combined surgery is postoperative anterior chamber inflammatory response, and with it, the formation of posterior synechia, reaching an average of 18 percent.

The development of posterior synechia interferes with postoperative visualization of the fundus, thus diminishing an important advantage of the combined procedure. Moreover, in a few cases, it can even be complicated by angle closure glaucoma.

Currently, there is no consensus on whether postoperative treatment after combined surgery should include additional treatment to help prevent the formation of synechia. The frequency and severity of posterior synechia after a combined operation may be reduced using short-acting mydriatics. However, there is no sufficient data nor a prospective study to support this as common practice. It is, therefore, we sought to better evaluate the effect of topical short-acting mydriatics on the formation of posterior synechia after combined surgery and compare it with standard postoperative treatment.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who underwent combined cataract and vitrectomy surgery with IOL implantation.

Exclusion criteria

• History of uveitis prior to surgery.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Control

No Intervention group

Description:

Control group receives standard post-operative treatment, which includes self-instillation of Ofloxacin and Dexamethasone eye drops with tapering down from q.i.d for the 1st week to once daily in the 4th week

Study

Experimental group

Description:

The study group receives standard post-operative treatment same as the control group. And additional treatment of a short-acting mydriatic agent (Cyclopentolate Hydrochloride 1.0% eye drops) t.i.d for 4 weeks (to operate eye alone)

Treatment:

Drug: Cyclopentolate Hydrochloride 1.0% eye drops