Mydriatic Drops After Combined Surgery

Not Applicable

Completed

• Conditions: Posterior Synechiae of Iris
• Interventions: Drug: Cyclopentolate Hydrochloride 1.0% eye drops

• Registration Number: NCT05614622
• Lead Sponsor: Rabin Medical Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-11-10
• Primary Completion: 2022-01-03
• Study Completion: 2022-01-03
• Study First Submitted: 2022-10-31
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-05
• Last Update Submitted: 2022-11-05
• Study First Posted: 2022-11-14
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• History of uveitis prior to surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study	Cyclopentolate Hydrochloride 1.0% eye drops	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)

Primary Outcome Measures

Name	Time	Method
Number of participants developed iris posterior synechiae after surgery	24 weeks	Iris posterior synechia is an adhesion formed between the iris and the capsular bag, which holds the implanted lens in place. It is a relatively common complication observed after intra-ocular surgery. Viewed under the slit lamp at the standard ophthalmologist examination after surgery.; Mild to Moderate synechia can interrupt pupil dilatation and interfere with postoperative visualization of the fundus, thus diminishing an advantage of the combined surgery.; Substantial synechia may affect the movement of the aqueous from the posterior to the anterior chamber resulting in secondary angle closure glaucoma.

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel